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A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

NCT00606229•Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I Disorder experiencing a manic or mixed episode

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
•Patients 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.
•Patients 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"
•Patients with a YMRS total score of 16 or more

Exclusion Criteria

•Patients 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
•Patients experiencing their first manic or mixed episode
•Patients whose current manic episode has lasted for more than 4 weeks
•Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
•Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders, but including abuse of benzodiazepines)
•Patients who have received ECT treatment within 8 weeks prior to informed consent
•Patients who are expected to require administration of ultrashort-acting or short-acting benzodiazepine receptor agonist hypnotics and antianxiety drugs (See (1) of 4.2.2) at doses exceeding the equivalent of 15 mg/day of diazepam (Only for those patients using such drugs)
+14 more criteria

Locations (5)

Chugoku Region, Japan

Hokuriku Region, Japan

Kanto Region, Japan

Kinki Region, Japan

Shikoku Region, Japan

Key Dates

Start Date

January 1, 2008

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

March 13, 2014

Enrollment

ACTUAL participants

Conditions

Bipolar I Disorder

Interventions

Aripiprazole

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

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