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NCT01588457 · ClinicalTrials.gov registry record · Phase 4
Sequential Multiple Assignment Treatment for 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
- 112
- Enrollment target
NCT01588457: Completed Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01588457 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 112 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01588457, 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
- 112 participants
- Enrollment target
Study Summary
The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar disorder over 26 weeks. The study will also compare if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus lithium or divalproex used with lamotrigine is more effective when symptoms of depression develop.
Primary Outcome
The BISS uses a structured interview to assess the full spectrum of symptoms associated with all primary clinical states in bipolar disorder, yielding a total severity, a depression, a mania, as well as dimensional scale scores. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows: 0 Not at all 1. Slight 2. Mild 3. Moderate 4. Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day p
Interventions
- DRUG Lamotrigine
- DRUG Lithium
- DRUG Quetiapine
- DRUG Divalproex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT01588457 record still lists
NCT01588457 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Lamotrigine is the first listed.
NCT01588457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01588457 about?
NCT01588457 is a clinical study titled "Sequential Multiple Assignment Treatment for Bipolar Disorder". The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar disorder over 26 weeks. The study will also compare if lithium or divalproex...
What is the current status of trial NCT01588457?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 112 participants. The study started on 2011-06. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01588457?
The interventions under investigation include: Lamotrigine (DRUG), Lithium (DRUG), Quetiapine (DRUG), Divalproex (DRUG).
Who is sponsoring clinical trial NCT01588457?
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 NCT01588457's enrollment target sits among peer trials
112 724th of 2000 higher than 1,275 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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