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NCT00029458 · ClinicalTrials.gov registry record · Phase 2
Clozapine for Treatment-Resistant Mania
A Phase 2 study of Bipolar Disorder, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00029458: Completed Phase 2 study of Bipolar Disorder, sponsored by National Institute of Mental Health (NIMH).
NCT00029458 is a Phase 2 study of Bipolar Disorder that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 42 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00029458, a Phase 2 study of Bipolar Disorder, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of clozapine as a treatment for the manic phase of bipolar disorder. A significant proportion of manic patients either do not respond adequately to conventional treatment or cannot tolerate the adverse effects associated with therapeutic doses of these agents. Clozapine may be a safe and effective treatment for mania. However, the efficacy of clozapine as an alternative therapy in treatment-resistant bipolar disorder mania has not been extensively researched. The study will be conducted in three phases. Phase 1 is a screening phase that will take place for 2 to 7 days. Participants will undergo a baseline positron emission tomography (PET) scan of the brain at the end of this period. In Phase 2, participants will be randomly assigned to receive either clozapine or placebo (an inactive pill) for 3 weeks. They may also receive lorazepam for the first 10 days of Phase 2. After 3 weeks, patients treated with clozapine will undergo a second PET scan. During Phase 3, participants who received placebo and did not improve will be offered clozapine for 3 weeks. Those who received clozapine and did not improve will receive other treatment for 3 weeks. At the end of Phase 3, participants who were treated with clozapine will have another PET scan.
Conditions Studied
Interventions
- DRUG Clozapine
Study Locations (1)
Maryland
- National Institute of Mental Health (NIMH) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2002-01 |
| Est. Completion | 2005-10 |
| Phase | Phase 2 |
What the finished NCT00029458 record still lists
NCT00029458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which Clozapine is the first listed.
NCT00029458 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00029458 about?
NCT00029458 is a clinical study titled "Clozapine for Treatment-Resistant Mania". The purpose of this study is to evaluate the safety and effectiveness of clozapine as a treatment for the manic phase of bipolar disorder. A significant proportion of manic patients either do not respond adequately to conventional treatment or cannot tolerate the adverse effects associated with the...
What is the current status of trial NCT00029458?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2002-01. Estimated completion is 2005-10.
What conditions does trial NCT00029458 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00029458?
The interventions under investigation include: Clozapine (DRUG).
Who is sponsoring clinical trial NCT00029458?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00029458 being conducted?
This trial has 1 study location across Maryland. 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 NCT00029458's enrollment target sits among peer trials
42 121st of 162 higher than 42 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
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