Social Anxiety DisorderPhase 3NCT00074802

Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder

A Phase 3 study testing Paroxetine and Cognitive behavioral therapy (CBT) in people with Social Anxiety Disorder, run by Temple University at 2 sites 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 to 65 years
Conditions the study is for: Social Anxiety Disorder
What is being tested?: Paroxetine and Cognitive behavioral therapy (CBT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 2 sitesUnited States
Study dates: Dec 2003to May 2008
Phase: Phase 3
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for generalized social phobia
Willing and able to give written informed consent
English-speaking

Who cannot join

Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders
Suicidal thoughts
History of failed paroxetine treatment of at least 6 weeks' duration at adequate doses or a history of failed outcome of a previous adequate trial of CBT
Clinically significant and/or unstable medical disease
Pregnancy or breast-feeding. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study through the use of an effective method of contraception.
Alcohol or substance abuse or dependence within the past 3 months. Patients with a positive drug screen but no substance abuse disorder will be eligible for the study, provided they have not met criteria for abuse/dependence within the last 6 months and provide two clean urine samples 2 weeks apart.

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Current or past history of seizure disorder (except febrile seizure in childhood)
Conditions that contraindicate the use of paroxetine
Inability to tolerate or unwillingness to accept a drug-free period of 4 weeks for monoamine oxidase inhibitors (MAOIs) or fluoxetine and 2 weeks for other selective serotonin reuptake inhibitors (SSRIs), neuroleptics, antidepressants, benzodiazepines, mood stabilizers, buspirone, beta-adrenergic blockers, or other psychotropic drugs prior to beginning the study
Currently receiving psychotherapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

New York State Psychiatric Institute Anxiety Disorders Clinic
New York, New York, 10032
Adult Anxiety Clinic of Temple University
Philadelphia, Pennsylvania, 19122-6085

Other trials in United States

About this study

Official title: CBT Augmentation of Paroxetine for Social Anxiety

This study will examine whether the addition of cognitive behavioral therapy can improve the efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder. Patients with social anxiety disorder will undergo a 12-week open trial with paroxetine. Those who complete the open trial having achieved only partial response will be randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to continue on paroxetine alone for an additional 16 weeks.

Read the detailed description

Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified. Paroxetine is effective in treating the acute symptoms of social anxiety, but many patients achieve less than optimal response. CBT has also been effective in treating social anxiety disorder; thus,it may also be effective in augmenting paroxetine response. This study will examine the effects of paroxetine treatment alone and in combination with CBT among patients who achieve less than optimal response after an open trial with paroxetine.

Participants in this study will receive paroxetine for 12 weeks (Phase 1). After 12 weeks, participants who have completed this open trial but have achieved some but less than optimal response will move forward to Phase 2. To be eligible to move forward to Phase 2, patients must have achieved at least a 10% improvement in their open-trial Liebowitz Social Anxiety Scale Scores (LSAS) but still have an LSAS score of 30 or greater. Patients meeting these criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. Social anxiety symptoms, rates of response and remission, fear of negative evaluation, disability and quality of life will be assessed.

Conditions: Social Anxiety Disorder
Being tested: Paroxetine, Cognitive behavioral therapy (CBT)
Keywords: Social Phobia
Medical subject headings: Phobia, Social

What participants receive

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

ParoxetineDrug
Also called Paxil
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Cognitive behavioral therapy (CBT)Behavioural
CBT will consist of 16 weekly treatment sessions.

Study groups in NCT00074802
Study group	Role	What they receive
Paroxetine Continuation	Experimental	Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. Receives: Drug: Paroxetine
Paroxetine with CBT Augmentation	Experimental	Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks. Receives: Drug: Paroxetine; Behavioral: Cognitive behavioral therapy (CBT)

What is being measured

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

Liebowitz Social Anxiety Scale (LSAS)
The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Measured: Change measured from Week 12 to Week 28

Secondary outcomes (6)

Clinical Global Impression Improvement Scale (CGI-I)
The CGI-I is a 7-point clinician-administered scale measuring improvement in symptoms over time. Lower numbers represent greater improvement. We examined responder status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1 or 2) as well as remission status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1) as secondary outcomes.
Measured: Responder and remitter status measured at Week 28
Social Interaction Anxiety Scale (SIAS)
The SIAS is a 20-item self-report measure of anxiety experienced while interacting in dyads or groups. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Measured: Change measured from Week 12 to Week 28
Social Phobia Scale (SPS)
The SPS is a 20-item self-report measure of anxiety experienced when being observed by others. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Measured: Change measured from Week 12 to Week 28
Brief Fear of Negative Evaluation Scale (BFNE)
The BFNE is a 12-item self-report measure of concern about negative evaluation by others. Items are rated on a 1-5 scale, yielding scores ranging from 12-60, with higher scores indicating greater fear of negative evaluation. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Measured: Change measured from Week 12 to Week 28
Liebowitz Self-Report Disability Scale (LSRDS)
The LSRDS is an 11-item self-report measure of the degree to which one's emotional problems limit one's ability to function in a variety of domains. Items are rated on a 0-3 scale of severity, and 10 of the 11 items (choosing either school or work as one area and omitting the other) are summed to produce a total score, ranging from 0-30. Higher scores represent greater disability. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Measured: Change measured from Week 12 to Week 28
Quality of Life Inventory (QOLI)
The QOLI is a 16-item self-report measure of life satisfaction. Each item is rated for importance (0-2) and satisfaction (-3 to +3), and these ratings are multiplied, summed, and divided by the number of non-zero entries to yield an average item score, which can range from -6 to +6. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Measured: Change measured from Week 12 to Week 28

Timeline

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

Dec 2003May 2008

First posted22 Dec 2003 (estimated)
Study startDec 2003
Primary completionMay 2008
Study completionMay 2008

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.
Other trials for Social 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Open trial of paroxetine (Phase 1) followed by randomization to either continued paroxetine or continued paroxetine plus cognitive behavioral therapy (Phase 2) for patients showing partial response to paroxetine in Phase 1.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00074802
Sponsor's protocol ID: R01MH064481
Other IDs: R01MH064481, DSIR 83-ATAS, R01MH064726, GSK ID: 101618
Status last verified: May 2017
First submitted: 19 Dec 2003
Last updated: 14 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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All Social Anxiety Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CBT Augmentation of Paroxetine for Social Anxiety
ClinicalTrials.gov ID: NCT00074802
Acronym / sponsor ID: R01MH064481
Conditions: Social Anxiety Disorder
Keywords: Social Phobia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Dec 2003
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 22 Dec 2003 (estimated)
Results: Posted 14 Jun 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Open trial of paroxetine (Phase 1) followed by randomization to either continued paroxetine or continued paroxetine plus cognitive behavioral therapy (Phase 2) for patients showing partial response to paroxetine in Phase 1.

Arm	Type	Receives
Paroxetine Continuation	Experimental	Drug: ParoxetineParticipants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Paroxetine with CBT Augmentation	Experimental	Drug: Paroxetine, Behavioral: Cognitive behavioral therapy (CBT)Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for generalized social phobia
Willing and able to give written informed consent
English-speaking

Key exclusion criteria (10 listed)

Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders
Suicidal thoughts
History of failed paroxetine treatment of at least 6 weeks' duration at adequate doses or a history of failed outcome of a previous adequate trial of CBT
Clinically significant and/or unstable medical disease
Pregnancy or breast-feeding. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study through the use of an effective method of contraception.

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
ParoxetineAlso: PaxilTreatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.	Drug	Paroxetine Continuation, Paroxetine with CBT Augmentation
Cognitive behavioral therapy (CBT)CBT will consist of 16 weekly treatment sessions.	Behavioural	Paroxetine with CBT Augmentation

Primary outcome

Liebowitz Social Anxiety Scale (LSAS)
Time frame: Change measured from Week 12 to Week 28
The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.

6 secondary outcomes

Clinical Global Impression Improvement Scale (CGI-I)
Time frame: Responder and remitter status measured at Week 28
Social Interaction Anxiety Scale (SIAS)
Time frame: Change measured from Week 12 to Week 28
Social Phobia Scale (SPS)
Time frame: Change measured from Week 12 to Week 28
Brief Fear of Negative Evaluation Scale (BFNE)
Time frame: Change measured from Week 12 to Week 28
Liebowitz Self-Report Disability Scale (LSRDS)
Time frame: Change measured from Week 12 to Week 28
Quality of Life Inventory (QOLI)
Time frame: Change measured from Week 12 to Week 28

Results and safety

Results posted to the registry on 14 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paroxetine Continuation	29	20
Paroxetine With CBT Augmentation	32	25

Primary outcome: Liebowitz Social Anxiety Scale (LSAS)

Time frame: Change measured from Week 12 to Week 28. Mean (Standard Deviation). Unit: units on a scale

Measure	Paroxetine Continuation n = 29	Paroxetine With CBT Augmentation n = 32
Value	7.77 (22.49)	7.84 (17.15)

Paroxetine Continuation vs Paroxetine With CBT Augmentation: Mean Difference (Net): -5.43 (95% CI -15.05 to 4.19), p = .267, Mixed Models Analysis

Population analysed: Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were assessed from the beginning of the open trial phase of the study and throughout the randomized phase in which patients received paroxetine with or without CBT. Data presented in the Serious Adverse Events (SAE) and AE tables refer to events occurring during the randomized phase (Weeks 12, 16, 20, 24, and 28).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paroxetine Continuation	1 of 29 (3.4%)	29 of 29 (100%)	0 of 29
Paroxetine With CBT Augmentation	0 of 32 (0%)	29 of 32 (90.6%)	0 of 32

Limitations and caveats (from the sponsor): Limitations include the small size of the randomized sample and the lack of a placebo arm in the randomization phase of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Richard Heimberg, PhD principal investigator

Adult Anxiety Clinic of Temple University

Michael Liebowitz, MD principal investigator

New York State Psychiatric Institute Anxiety Disorders Clinic

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paroxetine and Cognitive behavioral therapy (CBT) in people with Social Anxiety Disorder, run by Temple University at 2 sites 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 3 inclusion and 10 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Jun 2017). 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?

Liebowitz Social Anxiety Scale (LSAS) (time frame: Change measured from Week 12 to Week 28). 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 NCT00074802.

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 14 Jun 2017.