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Safety and Efficacy of Cariprazine for Mania

Primary Purpose

Bipolar Disorder, Mania

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Acute Mania, Bipolar I Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have provided informed consent prior to any study specific procedures
  • Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
  • Voluntarily hospitalized for current manic episode
  • Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months

Sites / Locations

  • Forest Investigative Site 004
  • Forest Investigative Site 005
  • Forest Investigative Site 007
  • Forest Investigative Site 009
  • Forest Investigative Site 006
  • Forest Investigative Site 001
  • Forest Investigative Site 003
  • Forest Investigative Site 008
  • Forest Investigative Site 010
  • Forest Investigative Site 002
  • Forest Investigative Site 106
  • Forest Investigative Site 112
  • Forest Investigator Site 108
  • Forest Investigative Site 103
  • Forest Investigative Site 120
  • Forest Investigative Site 105
  • Forest Investigative Site 107
  • Forest Investigative Site 118
  • Forest Investigative Site 113
  • Forest Investigative Site 115
  • Forest Investigative Site 114
  • Forest Investigative Site 101
  • Forest Investigative Site 110
  • Forest Investigative Site 111
  • Forest Investigative Site 104
  • Forest Investigative Site 121
  • Forest Investigative Site 109
  • Forest Investigative Site 119

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cariprazine

Placebo

Arm Description

Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.

Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.

Secondary Outcome Measures

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.

Full Information

First Posted
January 27, 2010
Last Updated
March 1, 2017
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01058096
Brief Title
Safety and Efficacy of Cariprazine for Mania
Official Title
A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine
Arm Type
Experimental
Arm Description
Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.
Primary Outcome Measure Information:
Title
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
Description
The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Time Frame
Baseline, Week 3
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
Description
The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Time Frame
Baseline, Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have provided informed consent prior to any study specific procedures Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms Voluntarily hospitalized for current manic episode Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG) Exclusion Criteria: Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Diaz, MD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 004
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Forest Investigative Site 005
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Forest Investigative Site 007
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Forest Investigative Site 009
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Forest Investigative Site 006
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Forest Investigative Site 001
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Forest Investigative Site 003
City
Creve Couer
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 008
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Forest Investigative Site 010
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Forest Investigative Site 002
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Forest Investigative Site 106
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Facility Name
Forest Investigative Site 112
City
Vizag
State/Province
Andhra Pradesh
ZIP/Postal Code
530017
Country
India
Facility Name
Forest Investigator Site 108
City
Varanasi
State/Province
Durgakund
ZIP/Postal Code
221005
Country
India
Facility Name
Forest Investigative Site 103
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Facility Name
Forest Investigative Site 120
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Forest Investigative Site 105
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
Facility Name
Forest Investigative Site 107
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Facility Name
Forest Investigative Site 118
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
Forest Investigative Site 113
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575018
Country
India
Facility Name
Forest Investigative Site 115
City
Manipal
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Facility Name
Forest Investigative Site 114
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Forest Investigative Site 101
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431005
Country
India
Facility Name
Forest Investigative Site 110
City
Nasik
State/Province
Maharashtra
ZIP/Postal Code
422101
Country
India
Facility Name
Forest Investigative Site 111
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Forest Investigative Site 104
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Facility Name
Forest Investigative Site 121
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600003
Country
India
Facility Name
Forest Investigative Site 109
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
200005
Country
India
Facility Name
Forest Investigative Site 119
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226006
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
31344528
Citation
McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5.
Results Reference
derived
PubMed Identifier
29017067
Citation
Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Cariprazine for Mania

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