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

To assess the safety and efficacy of long-term administration of aripiprazole by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those patients who completed the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") but whose condition worsened or remained unchanged or who discontinued Study 003 between Day 14 and Day 21 due to lack of drug efficacy.

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Key information

Conditions

Bipolar I Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria

Subjects who show exacerbation of condition or no change in condition: Those subjects who completed Study 003, and whose score for CGI-BP Change from preceding phase (mania) on Day 21 (completion of Study 003) was between 5 (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of condition), or whose score was 4 (No change) (subjects showing no change in condition)
Subjects who discontinued due to lack of drug efficacy: Those subjects who discontinued Study 003 between Day 14 and Day 21, for whom the reason of withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse)

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, other quinolinone-skeleton compounds, lithium, or valproate
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

Treatment and study plan

Aripiprazole

Drug

oral, 24mg(4 tablets)/day

Other names: OPC-14597

Primary outcomes

Young Mania Rating Scale (YMRS)

Time frame: baseline (Day 1 of preceding study), Day 154 or at discontinuation

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). 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.

Secondary outcomes

Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)

Time frame: Baseline (Day 1 of preceding study) , Day 154 or at discontinuation

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).

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) was calculated for each treatment group.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Feb 1, 2008
Registry last updated: Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed