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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: Completed Phase 3 study of Anxiety and Bipolar Disorder, sponsored by University Hospitals Cleveland Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
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 |
What the finished NCT00671853 record still lists
NCT00671853 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (73% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Anxiety
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 NCT00671853's enrollment target sits among peer trials
120 139th of 364 higher than 222 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety 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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