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NCT00219349 · ClinicalTrials.gov registry record · Phase 4
Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT00219349 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 25 participants.
The verdict
NCT00219349, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study 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 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.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
- DRUG escitalopram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00219349
The ClinicalTrials.gov registry entry for NCT00219349 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT00219349 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00219349 about?
NCT00219349 is a clinical study titled "Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)". 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 thera...
What is the current status of trial NCT00219349?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2005-01. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00219349?
The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), escitalopram (DRUG).
Who is sponsoring clinical trial NCT00219349?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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