A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Bipolar I Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group-Comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606281
• Other study ID #: 031-06-003
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2008
• Last updated: January 16, 2014
• Start date: January 2008
• Est. completion date: November 2010

Study information

• Verified date: January 2014
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 20 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)

• Patients at significant risk of developing a severe adverse event. Patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the trial, or who have a history of such a condition.

• Patients who have received any of the following treatments during the screening period:

• Reserpine

• Levodopa, dopamine receptor stimulants

• Monoamine oxidase inhibitors

• Psychostimulants

• Thyroid hormones, antithyroid drugs

• Corticosteroids (other than topical preparations)

• Adrenaline

• All other investigational or unapproved agents

• ECT

• Light therapy

• For patients who take lithium, valproate, or carbamazepine within 3 days prior to commencement of investigational product administration, those patients with serum concentrations of lithium greater than 0.6 mmol/L, serum concentrations of valproate greater than 50 µg/mL, or serum concentrations of carbamazepine greater than 4 µg/mL

• Patients judged to have a diabetic blood glucose level (judgment based on use of a self-monitoring blood glucose meter permissible), or patients whose HbA1c is 6.5% or higher

• Patients with a history or a complication of diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar I Disorder

Intervention

Drug:
• Aripiprazole
oral, 24mg/day
• placebo
oral, 0mg(4tablets)/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Young Mania Rating Scale (YMRS)	Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA).; 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) elevated 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).	Day1, Day21	No
Secondary	Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania)	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, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA.	Day1, Day21	No