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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

Primary Purpose

Bipolar Disorder Mania

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Placebo
Lithium
Valproate
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder Mania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo + valproate or lithium

Aripiprazole + valproate or lithium

Arm Description

Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.

Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.

Outcomes

Primary Outcome Measures

Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)
The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.

Secondary Outcome Measures

Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)
Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)
Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)
Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)
The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.
Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)
Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases.
Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)
Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.
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)
Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.
Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)
Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases.
Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)
Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.
Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)
Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.
Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)
BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward.

Full Information

First Posted
April 18, 2008
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00665366
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder Mania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
493 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + valproate or lithium
Arm Type
Placebo Comparator
Arm Description
Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
Arm Title
Aripiprazole + valproate or lithium
Arm Type
Active Comparator
Arm Description
Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify, BMS-337039
Intervention Description
5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, once daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Lithium
Intervention Description
Participant's ongoing dose
Intervention Type
Drug
Intervention Name(s)
Valproate
Intervention Description
Participant's ongoing dose
Primary Outcome Measure Information:
Title
Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)
Description
The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)
Description
Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Time Frame
Baseline to Weeks 3, 6, 9, and 12
Title
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)
Description
Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Time Frame
Baseline to Weeks 3, 6, 9, and 12
Title
Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)
Description
Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)
Description
The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.
Time Frame
Baseline to Weeks 3, 6, 9, and 12
Title
Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)
Description
Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases.
Time Frame
Baseline to Weeks 3, 6, 9, and 12
Title
Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)
Description
Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.
Time Frame
Baseline to Weeks 3,6, 9, and 12
Title
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)
Description
Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.
Time Frame
Baseline to Weeks 6 and 12
Title
Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)
Description
Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases.
Time Frame
Baseline to Weeks 3, 6, 9, and 12
Title
Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)
Description
Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.
Time Frame
Baseline to Weeks 3, 6, 9, and 12
Title
Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)
Description
Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.
Time Frame
Baseline to Weeks 3, 6, 9, and12
Title
Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)
Description
BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Local Institution
City
Litomerice
ZIP/Postal Code
41201
Country
Czech Republic
Facility Name
Local Institution
City
Prague 2
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
Local Institution
City
Praha 10
ZIP/Postal Code
101 00
Country
Czech Republic
Facility Name
Local Institution
City
Praha
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Local Institution
City
Beaupuy
ZIP/Postal Code
31850
Country
France
Facility Name
Local Institution
City
Brumath Cedex
ZIP/Postal Code
67173
Country
France
Facility Name
Local Institution
City
Chateau Gontier
ZIP/Postal Code
53200
Country
France
Facility Name
Local Institution
City
Clermont-Ferrand Cedex
ZIP/Postal Code
63001
Country
France
Facility Name
Local Institution
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Local Institution
City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
Local Institution
City
Jonzac Cedex
ZIP/Postal Code
175003
Country
France
Facility Name
Local Institution
City
Le Vesinet
ZIP/Postal Code
78110
Country
France
Facility Name
Local Institution
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75116
Country
France
Facility Name
Local Institution
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Local Institution
City
Saint Nazaire Cedex
ZIP/Postal Code
44606
Country
France
Facility Name
Local Institution
City
Sotteville Les Rouen
ZIP/Postal Code
76300
Country
France
Facility Name
Local Institution
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution
City
Ellwangen
ZIP/Postal Code
73479
Country
Germany
Facility Name
Local Institution
City
Ostfildern
ZIP/Postal Code
73760
Country
Germany
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
151 26
Country
Greece
Facility Name
Local Institution
City
Leros
ZIP/Postal Code
85400
Country
Greece
Facility Name
Local Institution
City
Nea Ionia-Athens
ZIP/Postal Code
14233
Country
Greece
Facility Name
Local Institution
City
Tripolis
ZIP/Postal Code
22100
Country
Greece
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Local Institution
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Local Institution
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Local Institution
City
Campobasso
ZIP/Postal Code
86100
Country
Italy
Facility Name
Local Institution
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Local Institution
City
Foligno (Pg)
ZIP/Postal Code
06034
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution
City
La Spezia
ZIP/Postal Code
19124
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Local Institution
City
Sant'Arsenio (Salerno)
ZIP/Postal Code
84037
Country
Italy
Facility Name
Local Institution
City
Choroszcz
ZIP/Postal Code
16070
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
30-393
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60-572
Country
Poland
Facility Name
Local Institution
City
Swiecie N/Wisla
ZIP/Postal Code
86-100
Country
Poland
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
041915
Country
Romania
Facility Name
Local Institution
City
Cluj-Nappoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Local Institution
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Local Institution
City
Khotkovo
ZIP/Postal Code
141371
Country
Russian Federation
Facility Name
Local Institution
City
Krasnodar
ZIP/Postal Code
350087
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Local Institution
City
Rostov-On-Don
ZIP/Postal Code
344010
Country
Russian Federation
Facility Name
Local Institution
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
Local Institution
City
St.Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Local Institution
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
Local Institution
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Local Institution
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Local Institution
City
Vereeniging
State/Province
Gauteng
ZIP/Postal Code
1939
Country
South Africa
Facility Name
Local Institution
City
Pinetown
State/Province
Kwa Zulu Natal
ZIP/Postal Code
3600
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Local Institution
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Local Institution
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Local Institution
City
Denizli
ZIP/Postal Code
20100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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