Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00223496 · ClinicalTrials.gov registry record · Phase 4
12- Week Open Label Treatment of Refractory Bipolar Depression
A Phase 4 study of Bipolar Disorder, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT00223496: Completed Phase 4 study of Bipolar Disorder, sponsored by The University of Texas Health Science Center at San Antonio.
NCT00223496 is a Phase 4 study of Bipolar Disorder that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 32 participants, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00223496, a Phase 4 study of Bipolar Disorder, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
1. Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks 2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression
Primary Outcome
Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).
Conditions Studied
Interventions
- DRUG Aripiprazole
Study Locations (1)
Texas
- Univ of Texas Helath Science Center at San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-09 |
| Phase | Phase 4 |
What the finished NCT00223496 record still lists
NCT00223496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Aripiprazole is the first listed.
NCT00223496 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00223496 about?
NCT00223496 is a clinical study titled "12- Week Open Label Treatment of Refractory Bipolar Depression". 1. Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks 2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression
What is the current status of trial NCT00223496?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2004-09. Estimated completion is 2009-09.
What conditions does trial NCT00223496 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00223496?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00223496?
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.
Where is trial NCT00223496 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
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 NCT00223496's enrollment target sits among peer trials
32 134th of 162 higher than 28 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
RECRUITING · Phase 4
-
FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder
COMPLETED · Phase 4
-
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
COMPLETED · Phase 4
-
Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
COMPLETED · Phase 4
-
Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence
COMPLETED · Phase 4
-
Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02445781 · 32 participants · Early Phase 1
Differing Levels of Hypoglycemia
- NCT02792270 · 32 participants · NA
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- NCT03068910 · 32 participants · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- NCT03208868 · 32 participants · NA
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia