Back to resultsStudy Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cariprazine (RGH-188)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Mania, Bipolar I Disorder, Acute Mania Associated with Bipolar I Disorder
Eligibility Criteria
Inclusion Criteria:
- Male or female inpatients 18 to 65 years of age
- Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode
Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4 on two of the following YMRS items:
- Irritability,
- Speech,
- Content, and
- Disruptive/Aggressive Behavior
Exclusion Criteria:
- Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values [such as thyroid-stimulating hormone (TSH)].
- Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score >= 18 at Visit 2.
- Patients experiencing first manic episode.
- Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.
Sites / Locations
- For information regarding investigative sites, contact Forest Professional Affairs
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 five-point scale (0-4) and 4-items on a nine-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. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate.
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. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate.
Full Information
NCT ID
NCT00488618
First Posted
June 19, 2007
Last Updated
March 1, 2017
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00488618
Brief Title
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
Official Title
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 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
June 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (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
This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Mania, Bipolar I Disorder, Acute Mania Associated with Bipolar I Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (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 (RGH-188)
Intervention Description
Cariprazine 3 mg - 12 mg oral administration, once per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-matched placebo oral administration, once per day.
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 five-point scale (0-4) and 4-items on a nine-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. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate.
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. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate.
Time Frame
Baseline, 3 Weeks
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:
Male or female inpatients 18 to 65 years of age
Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode
Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4 on two of the following YMRS items:
Irritability,
Speech,
Content, and
Disruptive/Aggressive Behavior
Exclusion Criteria:
Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values [such as thyroid-stimulating hormone (TSH)].
Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score >= 18 at Visit 2.
Patients experiencing first manic episode.
Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.
Facility Information:
Facility Name
For information regarding investigative sites, contact Forest Professional Affairs
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63045
Country
United States
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
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Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
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