- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606177
A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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HongKong, China
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Chubu region, Japan
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Chugoku region, Japan
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Hokkaido region, Japan
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Hokuriku region, Japan
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Kanto region, Japan
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Kinki region, Japan
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Kyushu region, Japan
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Shikoku region, Japan
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Tohoku region, Japan
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Seoul, Korea, Republic of
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Taipei, Taiwan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
- Subjects have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
- Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
- Subjects who were enrolled in and have completed Study 003 and who meet the following criteria for demonstration of drug efficacy
Subjects demonstrating drug efficacy:
- Those subjects who completed Study 003 whose score for CGI-BP Change From Preceding Phase (mania) at the time of evaluation on Day 21 of Study 003 (completion) was between 1 (Very much improved) and 3 (Minimally improved)
Exclusion Criteria:
Subjects presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
- Delirium, dementia, amnestic disorder, or other cognitive disorders
- Schizophrenia or other psychotic disorder
- Personality disorder
- Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
- Subjects who represent a significant risk of committing suicide
- Subjects known to have a complication of allergy to aripiprazole or other quinolinone-skeleton compounds
- Subjects with a complication of neuroleptic malignant syndrome
- Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
- Subjects with a complication of paralytic ileus
- Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy
- Subjects with a complication of diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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oral, 24mg(4 tablets)/day
Other Names:
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Placebo Comparator: 2
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oral, 0mg(4tablets)/day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Young Mania Rating Scale (YMRS)
Time Frame: Baseline (Day 1 of preceding study) , Day 154 or at discontinuation
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Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group. YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). |
Baseline (Day 1 of preceding study) , Day 154 or at discontinuation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)
Time Frame: Baseline (Day 1 of preceding study), Day 154 or at discontinuation
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Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group. CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components-mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill). |
Baseline (Day 1 of preceding study), Day 154 or at discontinuation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- 031-06-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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