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NCT00671853 · ClinicalTrials.gov registry record · Phase 3
Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)
A Phase 3 study of Anxiety and Bipolar Disorder, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT00671853 is a Phase 3 study of Anxiety and Bipolar Disorder that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 120 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00671853, a Phase 3 study of Anxiety and Bipolar Disorder, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The secondary aim is to generate an estimate of effect size to power a definitive large-scale, multi-site collaborative R01 and to configure the use of the primary and secondary outcome measures in the definitive large-scale study.
Conditions Studied
Interventions
- DRUG Quetiapine XR
- DRUG Placebo for quetiapine XR
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00671853
The ClinicalTrials.gov registry entry for NCT00671853 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (73% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Quetiapine XR is the first listed.
NCT00671853 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00671853 about?
NCT00671853 is a clinical study titled "Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)". The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The...
What is the current status of trial NCT00671853?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2008-04. Estimated completion is 2011-03.
What conditions does trial NCT00671853 study?
This clinical trial studies the following conditions: Anxiety, Bipolar Disorder, Substance Use Disorders, Anxiety Disorders.
What interventions are being tested in trial NCT00671853?
The interventions under investigation include: Quetiapine XR (DRUG), Placebo for quetiapine XR (DRUG).
Who is sponsoring clinical trial NCT00671853?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00671853 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.