Clinical trial NCT00665366: Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
Official title: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder Mania
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2008-04-23
Enrollment: 493
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.


Eligibility criteria: Key inclusion criteria:

* Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features
* Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole
* Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline
* Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.

Key exclusion criteria:

* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product
* A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder
* Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)
* Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania
* Thyroid pathology
* Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.
* History of neuroleptic malignant syndrome from antipsychotic agents
* Manic symptoms that investigator considers refractory to treatment
* Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms
* Significant risk of suicide based on history, mental status exam, or investigator judgment.

Primary outcomes:
measure: Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)
timeFrame: Baseline to Weeks 3, 6, 9, and 12
measure: Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)
timeFrame: Baseline to Weeks 3, 6, 9, and 12
measure: Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)
timeFrame: Baseline to Week 12
measure: Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)
timeFrame: Baseline to Weeks 3, 6, 9, and 12
measure: Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)
timeFrame: Baseline to Weeks 3, 6, 9, and 12
measure: Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)
timeFrame: Baseline to Weeks 3,6, 9, and 12
measure: Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)
timeFrame: Baseline to Weeks 6 and 12
measure: Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)
timeFrame: Baseline to Weeks 3, 6, 9, and 12
measure: Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)
timeFrame: Baseline to Weeks 3, 6, 9, and 12
measure: Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)
timeFrame: Baseline to Weeks 3, 6, 9, and12
measure: Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Litomerice
country: Czech Republic
facility: Local Institution
city: Prague 2
country: Czech Republic
facility: Local Institution
city: Praha 10
country: Czech Republic
facility: Local Institution
city: Praha
country: Czech Republic
facility: Local Institution
city: Beaupuy
country: France
facility: Local Institution
city: Brumath Cedex
country: France
facility: Local Institution
city: Chateau Gontier
country: France
facility: Local Institution
city: Clermont-Ferrand Cedex
country: France
facility: Local Institution
city: Dijon
country: France
facility: Local Institution
city: Dole
country: France
facility: Local Institution
city: Jonzac Cedex
country: France
facility: Local Institution
city: Le Vesinet
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Nimes
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Reims Cedex
country: France
facility: Local Institution
city: Saint Nazaire Cedex
country: France
facility: Local Institution
city: Sotteville Les Rouen
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Ellwangen
country: Germany
facility: Local Institution
city: Ostfildern
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Leros
country: Greece
facility: Local Institution
city: Nea Ionia-Athens
country: Greece
facility: Local Institution
city: Tripolis
country: Greece
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Gyor
country: Hungary
facility: Local Institution
city: Gyula
country: Hungary
facility: Local Institution
city: Campobasso
country: Italy
facility: Local Institution
city: Foggia
country: Italy
facility: Local Institution
city: Foligno (Pg)
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: La Spezia
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Sant'Arsenio (Salerno)
country: Italy
facility: Local Institution
city: Choroszcz
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Swiecie N/Wisla
country: Poland
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Cluj-Nappoca
country: Romania
facility: Local Institution
city: Iasi
country: Romania
facility: Local Institution
city: Khotkovo
country: Russian Federation
facility: Local Institution
city: Krasnodar
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Rostov-On-Don
country: Russian Federation
facility: Local Institution
city: Samara
country: Russian Federation
facility: Local Institution
city: St.Petersburg
country: Russian Federation
facility: Local Institution
city: Tomsk
country: Russian Federation
facility: Local Institution
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Soweto
country: South Africa
facility: Local Institution
state: Gauteng
city: Vereeniging
country: South Africa
facility: Local Institution
state: Gauteng
city: Pinetown
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Murcia
country: Spain
facility: Local Institution
city: Ankara
country: Turkey
facility: Local Institution
city: Antalya
country: Turkey
facility: Local Institution
city: Denizli
country: Turkey
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: