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NCT01195363 · ClinicalTrials.gov registry record · Phase 4
Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder
A Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT01195363: Completed Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01195363 is a Phase 4 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 28 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
NCT01195363, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.
Primary Outcome
The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.
Interventions
- DRUG quetiapine SR
- DRUG quetiapine sr placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-04 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
What the finished NCT01195363 record still lists
NCT01195363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 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 quetiapine SR is the first listed.
NCT01195363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01195363 about?
NCT01195363 is a clinical study titled "Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder". To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.
What is the current status of trial NCT01195363?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2007-04. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01195363?
The interventions under investigation include: quetiapine SR (DRUG), quetiapine sr placebo (DRUG).
Who is sponsoring clinical trial NCT01195363?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01195363's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 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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