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A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Lamotrigine + Aripiprazole
Lamotrigine + Placebo
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 focused on measuring Bipolar I Disorder with a recent manic or mixed episode

Eligibility Criteria

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

Inclusion Criteria: Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic Exclusion Criteria: First manic episode Current manic or mixed episode with > 2 years duration Treated with aripiprazole within the past 3 months Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine

Sites / Locations

  • University Of Alabama At Birmingham
  • Southwest Biomedical Research Foundation
  • Pravin Kansagra, M.D.
  • College Hospital Costa Mesa
  • Pacific Institute For Medical Research, Inc.
  • Excell Research
  • Southern Ca Clinical Research, Inc.
  • Stanford University
  • Los Angeles Biomedical Research Institute
  • Pacific Clinical Research Medical Group
  • Health Sciences America, Llc
  • Cns Clinical Research Group
  • Act Clinical Research Institute, Llc
  • Neuropsychiatric Research Center Of Southwest Florida
  • Aurora-Cuervo Clinical Trials
  • Gulf Coast Medical Research
  • Janus Center For Psychiatric Research
  • Comprehensive Neuroscience, Inc
  • Valle Vista Health System
  • Clinco
  • Clinical Trials Technology, Inc
  • Clinical Research Institute
  • University Of Kentucky, Dept. Of Psychiatry
  • Owensboro Behavioral Care
  • Sheppard Pratt Health System
  • Clinical Insights
  • Capital Clinical Research Associates
  • Psychopharmacology Research Corporation
  • University Of Minnesota
  • Regions Hospital
  • Precise Research Centers
  • University Of Medicine & Dentistry Of New Jersey
  • Buffalo Psychiatric Center
  • Finger Lakes Clinical Research
  • Richmond Behavioral Associates
  • Duke University Medical Center
  • Zarzar Psychiatric Associates, Pllc
  • Horizon Medical Services
  • Neuro Behavioral Clinical Research, Inc.
  • Community Research
  • Saroj Brar Md, Inc
  • University Of Oklahoma Health Sciences Center
  • Cutting Edge Research
  • Summit Research Network
  • Lehigh Valley Hospital
  • Lehigh Center For Clinical Research
  • Dubois Regional Medical Center
  • Freimer, Martin
  • University Of Pennsylvania
  • Belmont Center For Comprehensive Treatment
  • Cns Research Institute
  • Ut Medical Group/Odyssey Research
  • Psychiatric Consultants, Pc
  • Harmony Research, Llc
  • Bayou City Research, Ltd.
  • Alamo Superior Research
  • University Of Virginia Health System
  • Windwood Centre
  • Pacific Institute Of Medical Sciences
  • Summit Research Network (Seattle) Llc
  • Health Research Center
  • Aurora Health Care
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A1

A2

Arm Description

Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole

Phase 2 Double-Blind Treatment: Lamotrigine + Placebo

Outcomes

Primary Outcome Measures

Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).

Secondary Outcome Measures

Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2
Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)
Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)
Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).
Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Adjusted Mean Change From Baseline in Body Weight, Phase 2
Adjusted for index mood episode and baseline assessment
Number of Participants Showing Clinically Relevant Weight Loss by Study Week
Weight Loss of at least a 7% decrease from Baseline.
Number of Participants Showing Clinically Relevant Weight Gain by Study Week
Weight gain of at least a 7% increase from Baseline.
Adjusted Mean Change From Baseline in BMI by Study Week
Adjusted for index mood episode and baseline assessment.
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment
Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block.
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment
In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient's pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.
Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)
Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)
Summary of Concomitant Medications, Phase 1
Summary of Concomitant Medications, Phase 2
Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.
Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.
Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,
The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.

Full Information

First Posted
January 13, 2006
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
NCT00277212
Brief Title
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Official Title
A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I Disorder with a recent manic or mixed episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Description
Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole
Arm Title
A2
Arm Type
Placebo Comparator
Arm Description
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo
Intervention Type
Drug
Intervention Name(s)
Lamotrigine + Aripiprazole
Other Intervention Name(s)
Abilify, BMS-337039
Intervention Description
Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day Aripiprazole 10-30 mg/day
Intervention Type
Drug
Intervention Name(s)
Lamotrigine + Placebo
Intervention Description
Tablets, Oral, once daily, Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day placebo 0 mg/day
Primary Outcome Measure Information:
Title
Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
Description
Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Time Frame
Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Secondary Outcome Measure Information:
Title
Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2
Description
Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Time Frame
Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Title
Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)
Description
Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Time Frame
Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Title
Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)
Description
Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).
Time Frame
Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Title
Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs
Description
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame
Throughout Phase 2 (up to 52 weeks)
Title
Adjusted Mean Change From Baseline in Body Weight, Phase 2
Description
Adjusted for index mood episode and baseline assessment
Time Frame
Baseline, Week 52
Title
Number of Participants Showing Clinically Relevant Weight Loss by Study Week
Description
Weight Loss of at least a 7% decrease from Baseline.
Time Frame
Weeks 12, 24, 36, 52
Title
Number of Participants Showing Clinically Relevant Weight Gain by Study Week
Description
Weight gain of at least a 7% increase from Baseline.
Time Frame
Weeks 12, 24, 36, 52
Title
Adjusted Mean Change From Baseline in BMI by Study Week
Description
Adjusted for index mood episode and baseline assessment.
Time Frame
Baseline, Weeks 12, 24, 36, 52
Title
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment
Description
Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block.
Time Frame
Throughout the study, up to Week 52
Title
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment
Description
In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient's pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.
Time Frame
Up to 52 Weeks
Title
Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)
Description
Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)
Time Frame
Throughout Phase 2 of the study, up to Week 52
Title
Summary of Concomitant Medications, Phase 1
Time Frame
Phase 1 (9 to 24 Week Single-blind Stabilization Phase)
Title
Summary of Concomitant Medications, Phase 2
Time Frame
Phase 2 (52 Week Double-blind Relapse Assessment Phase)
Title
Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
Description
The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.
Time Frame
Baseline, Weeks 8, 24, 36, 52
Title
Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
Description
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.
Time Frame
Baseline, Weeks 8, 24, 36, 52
Title
Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,
Description
The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.
Time Frame
Baseline, Weeks 8, 24, 36, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic Exclusion Criteria: First manic episode Current manic or mixed episode with > 2 years duration Treated with aripiprazole within the past 3 months Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine
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
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Southwest Biomedical Research Foundation
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Pravin Kansagra, M.D.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
College Hospital Costa Mesa
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Pacific Institute For Medical Research, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Southern Ca Clinical Research, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Los Angeles Biomedical Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Health Sciences America, Llc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Cns Clinical Research Group
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
Act Clinical Research Institute, Llc
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32124
Country
United States
Facility Name
Neuropsychiatric Research Center Of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Aurora-Cuervo Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Gulf Coast Medical Research
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Janus Center For Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Comprehensive Neuroscience, Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Valle Vista Health System
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Clinco
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Clinical Trials Technology, Inc
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Clinical Research Institute
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67213
Country
United States
Facility Name
University Of Kentucky, Dept. Of Psychiatry
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Owensboro Behavioral Care
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Clinical Insights
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Capital Clinical Research Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Psychopharmacology Research Corporation
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
University Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Regions Hospital
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
University Of Medicine & Dentistry Of New Jersey
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Buffalo Psychiatric Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14213
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Zarzar Psychiatric Associates, Pllc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Horizon Medical Services
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Neuro Behavioral Clinical Research, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Saroj Brar Md, Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44113
Country
United States
Facility Name
University Of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cutting Edge Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Lehigh Center For Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Dubois Regional Medical Center
City
Dubois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
Facility Name
Freimer, Martin
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Belmont Center For Comprehensive Treatment
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
Cns Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Ut Medical Group/Odyssey Research
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Psychiatric Consultants, Pc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Harmony Research, Llc
City
Piney Flats
State/Province
Tennessee
ZIP/Postal Code
37686
Country
United States
Facility Name
Bayou City Research, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Alamo Superior Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Windwood Centre
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Pacific Institute Of Medical Sciences
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Summit Research Network (Seattle) Llc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Health Research Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Local Institution
City
Cabo Rojo
ZIP/Postal Code
00623
Country
Puerto Rico
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Local Institution
City
Rio Piedras
ZIP/Postal Code
00926
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

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