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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: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT00219349 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT00219349 record still lists
NCT00219349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT00219349 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00219349's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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