Generalized Anxiety DisorderPhase 4NCT00266409

Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

A Phase 4 study testing Niravam and SSRI/SNRI in people with Generalized Anxiety Disorder and Panic Disorder, run by UCB Pharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Generalized Anxiety Disorder, Panic Disorder
What is being tested?: Niravam and SSRI/SNRI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 418 participants
Where: 1 siteUnited States
Study dates: Oct 2005to Jun 2006
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be at least 18 years of age.
Diagnosed by the Investigator with primary Generalized Anxiety Disorder (GAD) and/or primary Panic Disorder with or without agoraphobia, either primary episode or recurrence, and is positive for GAD or Panic Disorder by the MHS (Mental Health Screener)).
Receiving a new prescription for all SSRI or SNRI as indicated for GAD or Panic Disorder with or without agoraphobia. Definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of SSRI or SNRI for the past 6 months.
Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent.

Who cannot join

Presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the Investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial.
Is a current suicide risk in the opinion of the Investigator.
Has initiated cognitive therapy within two months of Study Day 1.
Does not speak English or does not hear well enough to be able to perform the Hamilton Anxiety (HAM-A) Rating Scale and Mental Health Screener (MHS) by Interactive Voice Response System (IVRS).
Has taken a benzodiazepine within the past 30 days.
History of hypersensitivity or allergic response to any of the components of SSRIs, SNRIs, benzodiazepines, or related drugs.

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If a female of child-bearing potential, is pregnant, nursing, or not using appropriate birth control methods.
Presence of contraindications to the SSRI or SNRI to be prescribed per the specific package insert.
Presence of acute narrow angle glaucoma or taking ketoconazole or itraconazole,which are contraindications to Niravam per the package insert.
History of phenylketonuria (PKU).
Participation in a previous clinical trial within 30 days prior to Study Day 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

Schwarz
Milwaukee, Wisconsin

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Open-label, Parallel Design Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.

Conditions: Generalized Anxiety Disorder, Panic Disorder
Being tested: Niravam, SSRI/SNRI
Medical subject headings: Generalized Anxiety Disorder, Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NiravamDrug
Also called Alprazolam
SSRI/SNRIDrug
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor

Study groups in NCT00266409
Study group	Role	What they receive
Panic: Niravam+SSRI/SNRI	Experimental	Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI Receives: Drug: Niravam; Drug: SSRI/SNRI
Panic: SSRI/SNRI alone	Experimental	Panic Disorder: Newly prescribed SSRI or SNRI alone Receives: Drug: SSRI/SNRI
GAD: Niravam+SSRI/SNRI	Experimental	Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI Receives: Drug: Niravam; Drug: SSRI/SNRI
GAD: SSRI/SNRI alone	Experimental	Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone Receives: Drug: SSRI/SNRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Measured: 10 weeks
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Measured: 10 weeks

Secondary outcomes (67)

Change From Baseline in the Total HAM-A Score After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Measured: Baseline and 1 week
Change From Baseline in the Total HAM-A Score After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Measured: Baseline and 2 Weeks
Change From Baseline in the Total HAM-A Score After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Measured: Baseline and 3 weeks
Change From Baseline in the Total HAM-A Score After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Measured: Baseline and 4 weeks
Change From Baseline in the Total HAM-A Score After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Measured: Baseline and 5 weeks
Change From Baseline in the Total HAM-A Score After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Measured: Baseline and 6 weeks
Change From Baseline in the Total HAM-A Score After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Measured: Baseline and 7 weeks
Change From Baseline in the Total HAM-A Score After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Measured: Baseline and 8 weeks
Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.
Measured: Baseline and at endpoint during the 8 week treatment period
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Measured: 1 week
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Measured: 2 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Measured: 3 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Measured: 4 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Measured: 5 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Measured: 6 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Measured: 7 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Measured: 8 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period.
Measured: at endpoint during the 8 week treatment period
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Measured: Baseline and 2 weeks
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Measured: Baseline and 4 weeks
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Measured: Baseline and 8 weeks
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period.
Measured: Baseline and at endpoint during the 8 week treatment period
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Measured: 1 week
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.
Measured: 2 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Measured: 3 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Measured: 4 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Measured: 5 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Measured: 6 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Measured: 7 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Measured: 8 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period.
Measured: at endpoint during the 8 week treatment period
Change From Baseline in HAM-A-insomnia Subscore After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Measured: Baseline and 1 week
Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Measured: Baseline and 2 weeks
Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Measured: Baseline and 3 weeks
Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Measured: Baseline and 4 weeks
Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Measured: Baseline and 5 weeks
Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Measured: Baseline and 6 weeks
Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Measured: Baseline and 7 weeks
Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Measured: Baseline and 8 weeks
Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Measured: Baseline and at endpoint during the 8 week treatment period
Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Measured: Baseline and 1 week
Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Measured: Baseline and 2 weeks
Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Measured: Baseline and 3 weeks
Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Measured: Baseline and 4 weeks
Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Measured: Baseline and 5 weeks
Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Measured: Baseline and 6 weeks
Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Measured: Baseline and 7 weeks
Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Measured: Baseline and 8 weeks
Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Measured: Baseline and at endpoint during the 8 week treatment period
Change From Baseline in HAM-A-somatic Subscore After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Measured: Baseline and 1 week
Change From Baseline in HAM-A-somatic Subscore After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Measured: Baseline and 2 weeks
Change From Baseline in HAM-A-somatic Subscore After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Measured: Baseline and 3 weeks
Change From Baseline in HAM-A-somatic Subscore After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Measured: Baseline and 4 weeks
Change From Baseline in HAM-A-somatic Subscore After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Measured: Baseline and 5 weeks
Change From Baseline in HAM-A-somatic Subscore After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Measured: Baseline and 6 weeks
Change From Baseline in HAM-A-somatic Subscore After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Measured: Baseline and 7 weeks
Change From Baseline in HAM-A-somatic Subscore After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Measured: Baseline and 8 weeks
Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Measured: Baseline and at endpoint during the 8 week treatment period
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week
Measured: 1 week
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks
Measured: 2 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks
Measured: 3 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks
Measured: 4 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks
Measured: 5 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks
Measured: 6 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks
Measured: 7 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks
Measured: 8 weeks
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period
Endpoint is last observed value during the 8 week treatment period.
Measured: at endpoint during the 8 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Jun 2006

First posted16 Dec 2005 (estimated)
Study startOct 2005
Primary completionJun 2006
Study completionJun 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 418 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00266409
Sponsor's protocol ID: SP0851
Status last verified: Dec 2009
First submitted: 15 Dec 2005
Last updated: 27 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Katzelnick DJ, Saidi J, Vanelli MR, Jefferson JW, Harper JM, McCrary KE. Time to response in panic disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006 Dec;3(12):39-49.
PubMed 20877555
Rapaport MH, Skarky SB, Katzelnick DJ, Dewester JN, Harper JM, McCrary KE. Time to response in generalized anxiety disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006 Dec;3(12):50-9.
PubMed 20877556

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-label, Parallel Design Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder
ClinicalTrials.gov ID: NCT00266409
Acronym / sponsor ID: SP0851
Conditions: Generalized Anxiety Disorder, Panic Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 418 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Jun 2006 (actual)
Study completion: Jun 2006 (actual)
First posted: 16 Dec 2005 (estimated)
Results: Posted 2 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Panic: Niravam+SSRI/SNRI	Experimental	Drug: Niravam, Drug: SSRI/SNRIPanic Disorder: Niravam plus a newly prescribed SSRI or SNRI
Panic: SSRI/SNRI alone	Experimental	Drug: SSRI/SNRIPanic Disorder: Newly prescribed SSRI or SNRI alone
GAD: Niravam+SSRI/SNRI	Experimental	Drug: Niravam, Drug: SSRI/SNRIGeneralized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI
GAD: SSRI/SNRI alone	Experimental	Drug: SSRI/SNRIGeneralized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Must be at least 18 years of age.
Diagnosed by the Investigator with primary Generalized Anxiety Disorder (GAD) and/or primary Panic Disorder with or without agoraphobia, either primary episode or recurrence, and is positive for GAD or Panic Disorder by the MHS (Mental Health Screener)).
Receiving a new prescription for all SSRI or SNRI as indicated for GAD or Panic Disorder with or without agoraphobia. Definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of SSRI or SNRI for the past 6 months.
Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent.

Key exclusion criteria (11 listed)

Presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the Investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial.
Is a current suicide risk in the opinion of the Investigator.
Has initiated cognitive therapy within two months of Study Day 1.
Does not speak English or does not hear well enough to be able to perform the Hamilton Anxiety (HAM-A) Rating Scale and Mental Health Screener (MHS) by Interactive Voice Response System (IVRS).
Has taken a benzodiazepine within the past 30 days.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NiravamAlso: Alprazolam	Drug	GAD: Niravam+SSRI/SNRI, Panic: Niravam+SSRI/SNRI
SSRI/SNRISelective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor	Drug	GAD: Niravam+SSRI/SNRI, GAD: SSRI/SNRI alone, Panic: Niravam+SSRI/SNRI, Panic: SSRI/SNRI alone

Primary outcome

Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Time frame: 10 weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Time frame: 10 weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.

67 secondary outcomes

Change From Baseline in the Total HAM-A Score After 1 Week
Time frame: Baseline and 1 week
Change From Baseline in the Total HAM-A Score After 2 Weeks
Time frame: Baseline and 2 Weeks
Change From Baseline in the Total HAM-A Score After 3 Weeks
Time frame: Baseline and 3 weeks
Change From Baseline in the Total HAM-A Score After 4 Weeks
Time frame: Baseline and 4 weeks
Change From Baseline in the Total HAM-A Score After 5 Weeks
Time frame: Baseline and 5 weeks
Change From Baseline in the Total HAM-A Score After 6 Weeks
Time frame: Baseline and 6 weeks
Change From Baseline in the Total HAM-A Score After 7 Weeks
Time frame: Baseline and 7 weeks
Change From Baseline in the Total HAM-A Score After 8 Weeks
Time frame: Baseline and 8 weeks
Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period
Time frame: Baseline and at endpoint during the 8 week treatment period
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week
Time frame: 1 week
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks
Time frame: 2 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks
Time frame: 3 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks
Time frame: 4 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks
Time frame: 5 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks
Time frame: 6 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks
Time frame: 7 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks
Time frame: 8 weeks
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period
Time frame: at endpoint during the 8 week treatment period
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
Time frame: Baseline and 2 weeks
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
Time frame: Baseline and 4 weeks
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Time frame: Baseline and 8 weeks
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
Time frame: Baseline and at endpoint during the 8 week treatment period
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
Time frame: 1 week
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
Time frame: 2 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
Time frame: 3 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
Time frame: 4 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
Time frame: 5 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
Time frame: 6 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
Time frame: 7 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
Time frame: 8 weeks
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
Time frame: at endpoint during the 8 week treatment period
Change From Baseline in HAM-A-insomnia Subscore After 1 Week
Time frame: Baseline and 1 week
Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks
Time frame: Baseline and 2 weeks
Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks
Time frame: Baseline and 3 weeks
Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks
Time frame: Baseline and 4 weeks
Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks
Time frame: Baseline and 5 weeks
Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks
Time frame: Baseline and 6 weeks
Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks
Time frame: Baseline and 7 weeks
Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks
Time frame: Baseline and 8 weeks
Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period
Time frame: Baseline and at endpoint during the 8 week treatment period

Results and safety

Results posted to the registry on 2 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panic: Niravam+SSRI/SNRI	137	92
Panic: SSRI/SNRI Alone	138	92
GAD : Niravam+SSRI/SNRI	72	55
GAD: SSRI/SNRI Alone	71	49

Primary outcome: Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)

Time frame: 10 weeks. Number. Unit: cumulative percent of responders

Measure	Panic: Niravam+SSRI/SNRI n = 125	Panic: SSRI/SNRI Alone n = 120	GAD : Niravam+SSRI/SNRI n = 67	GAD: SSRI/SNRI Alone n = 62
Week 1	1.60	0.83	1.49	1.61
Week 2	3.20	21.73	32.93	27.52
Week 3	45.83	39.43	51.22	48.89
Week 4	59.22	52.40	57.32	62.14
Week 5	69.68	65.99	66.47	65.92
Week 6	71.57	69.79	69.66	71.94
Week 7	74.59	74.11	74.66	73.94
Week 8	76.62	76.27	76.47	73.94

Panic: Niravam+SSRI/SNRI vs Panic: SSRI/SNRI Alone: p = 0.1143, Generalized Wilcoxon
GAD : Niravam+SSRI/SNRI vs GAD: SSRI/SNRI Alone: p = 0.4544, Generalized Wilcoxon

Population analysed: Intent-to-treat population

Primary outcome: Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)

Time frame: 10 weeks. Number. Unit: cumulative percent of responders

Measure	Panic: Niravam+SSRI/SNRI n = 104	Panic: SSRI/SNRI Alone n = 106	GAD : Niravam+SSRI/SNRI n = 53	GAD: SSRI/SNRI Alone n = 49
Week 1	1.92	0.94	1.89	2.04
Week 2	35.58	24.53	33.96	30.78
Week 3	51.23	41.54	52.83	53.16
Week 4	63.18	54.19	58.49	67.21
Week 5	75.45	67.59	67.92	71.89
Week 6	77.59	71.94	71.70	79.56
Week 7	79.83	75.77	77.70	79.56
Week 8	80.95	78.32	79.93	79.56

Panic: Niravam+SSRI/SNRI vs Panic: SSRI/SNRI Alone: p = 0.044, Generalized Wilcoxon Test
GAD : Niravam+SSRI/SNRI vs GAD: SSRI/SNRI Alone: p = 0.6587, Generalized Wilcoxon Test

Population analysed: Per Protocol Population (subjects of ITT population who have no major protocol violations)

67 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panic: Niravam+SSRI/SNRI	3 of 137 (2.2%)	20 of 137 (14.6%)	Not reported
Panic: SSRI/SNRI Alone	2 of 135 (1.5%)	10 of 135 (7.4%)	Not reported
GAD : Niravam+SSRI/SNRI	0 of 71 (0%)	12 of 71 (16.9%)	Not reported
GAD: SSRI/SNRI Alone	2 of 71 (2.8%)	5 of 71 (7%)	Not reported

Limitations and caveats (from the sponsor): Originally it was planned to enrol and randomize 848 subjects. The smaller than planned sample size was a result of an unusually high rate of screening failure (results published in Psychiatry 2006, Vol. 3, Issue 12 , pages 39 - 59).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20877555Katzelnick DJ, Saidi J, Vanelli MR, Jefferson JW, Harper JM, McCrary KE. Time to response in panic disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006 Dec;3(12):39-49.
Results publication: PubMed 20877556Rapaport MH, Skarky SB, Katzelnick DJ, Dewester JN, Harper JM, McCrary KE. Time to response in generalized anxiety disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006 Dec;3(12):50-9.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Niravam and SSRI/SNRI in people with Generalized Anxiety Disorder and Panic Disorder, run by UCB Pharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00266409, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.