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Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00488618
First received: June 19, 2007
Last updated: March 1, 2017
Last verified: March 2017

June 19, 2007
March 1, 2017
June 2007
July 2008   (Final data collection date for primary outcome measure)
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 [ Time Frame: Baseline, 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.
YMRS
Complete list of historical versions of study NCT00488618 on ClinicalTrials.gov Archive Site
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 [ Time Frame: Baseline, 3 Weeks ]
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.
CGI-S
Not Provided
Not Provided
 
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in Patients With Acute Mania Associated With Bipolar I Disorder
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Cariprazine (RGH-188)
    Cariprazine 3 mg - 12 mg oral administration, once per day.
  • Drug: Placebo
    Dose-matched placebo oral administration, once per day.
  • Experimental: Cariprazine
    Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
    Intervention: Drug: Cariprazine (RGH-188)
  • Placebo Comparator: Placebo
    Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
July 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00488618
RGH-MD-31
No
Not Provided
Not Provided
Not Provided
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Not Provided
Forest Laboratories
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP