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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 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.

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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

Bipolar Disorder

Interventions

  • DRUG Clozapine

Study Locations (1)

Maryland

  • National Institute of Mental Health (NIMH) - Bethesda

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2002-01
Est. Completion 2005-10
Phase Phase 2

Sponsor

National Institute of Mental Health (NIMH)

343 total trials

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What the Registry Record Tells You About NCT00029458

The ClinicalTrials.gov registry entry for NCT00029458 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.