Generalized Anxiety DisorderPhase 4NCT00219349
Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
A Phase 4 study testing Cognitive Behavioral Therapy and escitalopram in people with Generalized Anxiety Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The goals of this pilot study are as follows: 1) To disseminate and examine the effectiveness of a manualized, individual, cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD), 2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in participants… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cognitive Behavioral Therapy and escitalopram
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jul 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between the ages of 18 and 65 (inclusive)
- Primary DSM-IV-TR diagnosis of Generalized Anxiety Disorder (GAD) with no significant co-morbid anxiety disorder for which CBT for GAD is not appropriate including PTSD, OCD, and prominent panic disorder with or without agoraphobia
- A negative urine toxicology, i.e., a urine specimen that does not test positive for use of drugs of abuse, or use of benzodiazepines, in the previous three weeks
- Penn State Worry Questionnaire score of 55 or greater
- Have a score of equal to or > 4 (Moderately Ill) on Clinical Global Impression (CGI) Scale (severity of illness item) for GAD
- Ability to give informed consent
- Fluent in English
- Willingness to have Cognitive-Behavioral Therapy sessions audiotaped -
Who cannot join
- Patients who have a diagnosis of Major Depressive Disorder within 60 days prior to the clinical interview, and patients who have a "lifetime" history of being diagnosed with one or more of the following disorders: Schizophrenia, Major Depressive Disorder with Psychotic or Catatonic features, Bipolar I Affective Disorder, or Organic Mental Disease
- DSM-IV substance abuse or dependence within the past 6 months (except nicotine or caffeine)
- Active suicidal or homicidal ideation, or judged to be at serious suicide risk
- Hamilton Rating Scale for Depression score of greater than 20 at Screening or Baseline evaluation
- Any unstable medical or neurological condition
- Women who are pregnant or lactating
Show all 10Show fewer
- Having received CBT treatment for GAD previously
- Concurrent psychosocial therapy
- Current psychotropic medication with exception of zolpidem at hs for insomnia
- History of nonresponse to an adequate trial of escitalopram or intolerable adverse effects to escitalopram -
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety Disorders Clinic, New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation
The goals of this pilot study are as follows:
- To disseminate and examine the effectiveness of a manualized, individual, cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD), 2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in participants who do not fully respond to CBT, and 3) to examine individual and clinical predictors of non-response to CBT and predictors of response to augmentation antidepressant therapy. A related goal is to examine the maintenance of treatment gains obtained from CBT alone and CBT with augmentation antidepressant therapy, over a twenty-four month follow-up period. This study will serve as a pilot investigation in preparation for a larger federally funded study using this treatment approach. We hypothesize that CBT will result in remission (no longer having GAD) and/or high endstate functioning (clinically meaningful improvement) in approximately 40-50% of participants. Further, we hypothesize that augmentation antidepressant therapy in participants who do not fully respond to CBT will result in further clinically significant improvement.
Read the detailed description
This pilot investigation will examine the effectiveness of augmenting cognitive behavioral therapy (CBT) with antidepressant pharmacotherapy (escitalopram[Lexapro]) in adults with generalized anxiety disorder (GAD) who do not fully respond to a temporally primary trial of CBT. A secondary aim of this study is to assess the maintenance of treatment gains made by patients in response to CBT, and to CBT with antidepressant augmentation therapy, over a two-year follow-up period.
CBT is an empirically supported psychotherapy that has been found to be effective in treating GAD in approximately 50 percent of patients enrolled in controlled clinical trials. However, a substantial proportion (nearly half) of individuals with GAD do not achieve full remission or clinically significant improvement at the cessation of CBT. Escitalopram (Lexapro)is a selective serotonin reuptake inhibitor (SSRI) antidepressant, which has been shown to be effective in treating GAD in several large-scale controlled clinical trials. The Food and Drug Administration has approved ecitalopram for the treatment of GAD.
The proposed research plan encompasses the conduct of an open clinical trial (No randomized placebo control) of 14 sessions of manualized individual CBT for persons meeting DSM-IV-TR diagnostic criteria for GAD. This study will use a treatment manual developed by Dr. Thomas Borkovec and colleagues at the Pennsylvania State University. Participants who meet high endstate functioning criteria and/or achieve remission following CBT will be evaluated periodically during a twenty-four month follow-up phase. Participants who do not meet high endstate functioning criteria and/or achieve remission following completion of CBT will be offered entry into a twelve-week, open-label, flexible-dose trial of escitalopram therapy. Participants receiving escitalopram therapy will be evaluated periodically during a twenty-four month follow-up phase, as well. It is anticipated that patients who do not fully respond to CBT will show a significant increment in improvement in GAD symptoms, over and above their CBT posttreatment level, following pharmacotherapy with escitalopram.
At present, no studies with GAD populations have examined the additive or sequenced effects of psychosocial therapy and SSRI antidepressant pharmacotherapy. The proposed research is a first step in this direction and may provide evidence supporting the use of combined treatment modalities in CBT partial and non-responders.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive Behavioral Therapy, escitalopram
- Keywords
- Anxiety Disorders, Anxiety Neuroses, Behavior Therapy, Cognitive, Escitalopram
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
14 weekly sessions of individualized CBT
escitalopramDrug
Also called lexapro
10-20 mg per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | 12 weeks of open label escitalopram, 10-20 mg/day (after 14 weeks of cognitive behavioral therapy Receives: Behavioral: Cognitive Behavioral Therapy; Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Anxiety Rating Scale Score
The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.
Measured: week 14 to week 26
Change in Clinical Global Impressions-Severity Index
7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.
Measured: week 14 to week 26
Change in Generalized Anxiety Disorder Severity Scale
measures severity of symptoms of generalized anxiety disorder, reported as a total score summing 10 items that are each rated from 0, never to 4, all of the time. Range is 0 to 40, with 40 most severe.
Measured: week 14 to week 26
Change in Penn State Worry Questionnaire
total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)
Measured: week 14 to week 26
Change in State-Trait Anxiety Inventory, State Subscale
only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)
Measured: week 14 to week 26
Secondary outcomes (3)
Clinical Global Impressions-Improvement Index
This is a single item rating overall symptomatic improvement. Range is 0 (very much worse) to 7 (very much improved)
Measured: week 26
Change in Hamilton Rating Scale for Depression
24 item version of this standard depression scale, total score ranges from 0 (not depressed) to 58 (most severe)
Measured: week 14 to week 26
Change in Beck Depression Inventory-II
total score ranges from 0 (not depressed) to 63 (most severe)
Measured: week 14 to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2008
- Study completionJul 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.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Franklin R. Schneier, M.D., Principal investigator, New York State Psychiatric InstituteKenneth D Belzer, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219349
- Sponsor's protocol ID
- #4941
- Status last verified
- Nov 2017
- First submitted
- 14 Sep 2005
- Last updated
- 19 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schneier FR, Belzer KD, Kishon R, Amsel L, Simpson HB. Escitalopram for persistent symptoms of generalized anxiety disorder after CBT: a pilot study. J Nerv Ment Dis. 2010 Jun;198(6):458-61. doi: 10.1097/NMD.0b013e3181da4d77.
PubMed 20531128
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation
- ClinicalTrials.gov ID
- NCT00219349
- Acronym / sponsor ID
- #4941
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Anxiety Disorders, Anxiety Neuroses, Behavior Therapy, Cognitive, Escitalopram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jan 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 9 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this pilot study are as follows:
- To disseminate and examine the effectiveness of a manualized, individual, cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD), 2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in participants who do not fully respond to CBT, and 3) to examine individual and clinical predictors of non-response to CBT and predictors of response to augmentation antidepressant therapy. A related goal is to examine the maintenance of treatment gains obtained from CBT alone and CBT with augmentation antidepressant therapy, over a twenty-four month follow-up period. This study will serve as a pilot investigation in preparation for a larger federally funded study using this treatment approach. We hypothesize that CBT will result in remission (no longer having GAD) and/or high endstate functioning (clinically meaningful improvement) in approximately 40-50% of participants. Further, we hypothesize that augmentation antidepressant therapy in participants who do not fully respond to CBT will result in further clinically significant improvement.
Detailed description
This pilot investigation will examine the effectiveness of augmenting cognitive behavioral therapy (CBT) with antidepressant pharmacotherapy (escitalopram[Lexapro]) in adults with generalized anxiety disorder (GAD) who do not fully respond to a temporally primary trial of CBT. A secondary aim of this study is to assess the maintenance of treatment gains made by patients in response to CBT, and to CBT with antidepressant augmentation therapy, over a two-year follow-up period.
CBT is an empirically supported psychotherapy that has been found to be effective in treating GAD in approximately 50 percent of patients enrolled in controlled clinical trials. However, a substantial proportion (nearly half) of individuals with GAD do not achieve full remission or clinically significant improvement at the cessation of CBT. Escitalopram (Lexapro)is a selective serotonin reuptake inhibitor (SSRI) antidepressant, which has been shown to be effective in treating GAD in several large-scale controlled clinical trials. The Food and Drug Administration has approved ecitalopram for the treatment of GAD.
The proposed research plan encompasses the conduct of an open clinical trial (No randomized placebo control) of 14 sessions of manualized individual CBT for persons meeting DSM-IV-TR diagnostic criteria for GAD. This study will use a treatment manual developed by Dr. Thomas Borkovec and colleagues at the Pennsylvania State University. Participants who meet high endstate functioning criteria and/or achieve remission following CBT will be evaluated periodically during a twenty-four month follow-up phase. Participants who do not meet high endstate functioning criteria and/or achieve remission following completion of CBT will be offered entry into a twelve-week, open-label, flexible-dose trial of escitalopram therapy. Participants receiving escitalopram therapy will be evaluated periodically during a twenty-four month follow-up phase, as well. It is anticipated that patients who do not fully respond to CBT will show a significant increment in improvement in GAD symptoms, over and above their CBT posttreatment level, following pharmacotherapy with escitalopram.
At present, no studies with GAD populations have examined the additive or sequenced effects of psychosocial therapy and SSRI antidepressant pharmacotherapy. The proposed research is a first step in this direction and may provide evidence supporting the use of combined treatment modalities in CBT partial and non-responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Behavioral: Cognitive Behavioral Therapy, Drug: escitalopram12 weeks of open label escitalopram, 10-20 mg/day (after 14 weeks of cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females between the ages of 18 and 65 (inclusive)
- Primary DSM-IV-TR diagnosis of Generalized Anxiety Disorder (GAD) with no significant co-morbid anxiety disorder for which CBT for GAD is not appropriate including PTSD, OCD, and prominent panic disorder with or without agoraphobia
- A negative urine toxicology, i.e., a urine specimen that does not test positive for use of drugs of abuse, or use of benzodiazepines, in the previous three weeks
- Penn State Worry Questionnaire score of 55 or greater
- Have a score of equal to or > 4 (Moderately Ill) on Clinical Global Impression (CGI) Scale (severity of illness item) for GAD
Key exclusion criteria (10 listed)
- Patients who have a diagnosis of Major Depressive Disorder within 60 days prior to the clinical interview, and patients who have a "lifetime" history of being diagnosed with one or more of the following disorders: Schizophrenia, Major Depressive Disorder with Psychotic or Catatonic features, Bipolar I Affective Disorder, or Organic Mental Disease
- DSM-IV substance abuse or dependence within the past 6 months (except nicotine or caffeine)
- Active suicidal or homicidal ideation, or judged to be at serious suicide risk
- Hamilton Rating Scale for Depression score of greater than 20 at Screening or Baseline evaluation
- Any unstable medical or neurological condition
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 |
|---|---|---|
| Cognitive Behavioral Therapy14 weekly sessions of individualized CBT | Behavioural | Escitalopram |
| escitalopramAlso: lexapro10-20 mg per day for 12 weeks | Drug | Escitalopram |
Primary outcome
Change in Hamilton Anxiety Rating Scale Score
Time frame: week 14 to week 26
The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.
Change in Clinical Global Impressions-Severity Index
Time frame: week 14 to week 26
7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.
Change in Generalized Anxiety Disorder Severity Scale
Time frame: week 14 to week 26
measures severity of symptoms of generalized anxiety disorder, reported as a total score summing 10 items that are each rated from 0, never to 4, all of the time. Range is 0 to 40, with 40 most severe.
Change in Penn State Worry Questionnaire
Time frame: week 14 to week 26
total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)
Change in State-Trait Anxiety Inventory, State Subscale
Time frame: week 14 to week 26
only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)
3 secondary outcomes
Clinical Global Impressions-Improvement Index
Time frame: week 26
Change in Hamilton Rating Scale for Depression
Time frame: week 14 to week 26
Change in Beck Depression Inventory-II
Time frame: week 14 to week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20531128Schneier FR, Belzer KD, Kishon R, Amsel L, Simpson HB. Escitalopram for persistent symptoms of generalized anxiety disorder after CBT: a pilot study. J Nerv Ment Dis. 2010 Jun;198(6):458-61. doi: 10.1097/NMD.0b013e3181da4d77.
- New York State Psychiatric Institute HomepageLink provided by the sponsor.
- Anxiety Disorders Association of America HomepageLink provided by the sponsor.
- 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.
Franklin R. Schneier, M.D. principal investigator
New York State Psychiatric Institute
Kenneth D Belzer, Ph.D. principal investigator
New York State Psychiatric Institute
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 Cognitive Behavioral Therapy and escitalopram in people with Generalized Anxiety Disorder, run by New York State Psychiatric Institute 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 8 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 19 Dec 2017. 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 9 May 2012). 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?
Change in Hamilton Anxiety Rating Scale Score (time frame: week 14 to week 26). The study lists 5 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 NCT00219349, which also lists 1 linked publication.
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 19 Dec 2017.