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NCT01971203 · ClinicalTrials.gov registry record · NA
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
A NA study of Major Depressive Disorder and Generalized Anxiety Disorder, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT01971203: Completed NA study of Major Depressive Disorder and Generalized Anxiety Disorder, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01971203 is a NA study of Major Depressive Disorder and Generalized Anxiety Disorder that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 62 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01971203, a NA study of Major Depressive Disorder and Generalized Anxiety Disorder, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to determine whether quetiapine extended-release in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo in treating depressive and anxiety symptoms in patients with both major depression and generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about 45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which medication will be discussed. Both clinician administered and self-report measures will be used to compare groups before and after 16 weeks.
Primary Outcome
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.
Conditions Studied
Interventions
- BEHAVIORAL CBT
- DRUG seroquel xr
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01971203 record still lists
NCT01971203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which CBT is the first listed.
NCT01971203 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01971203 about?
NCT01971203 is a clinical study titled "Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat". The primary objective of the study is to determine whether quetiapine extended-release in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo in treating depressive and anxiety symptoms in patients with both major depression and generalized anxiety disorder. A...
What is the current status of trial NCT01971203?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2009-09. Estimated completion is 2013-06.
What conditions does trial NCT01971203 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Generalized Anxiety Disorder.
What interventions are being tested in trial NCT01971203?
The interventions under investigation include: CBT (BEHAVIORAL), seroquel xr (DRUG).
Who is sponsoring clinical trial NCT01971203?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01971203 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01971203's enrollment target sits among peer trials
62 165th of 282 higher than 116 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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.
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