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

NCT00488618 | Completed Phase 2 Results

• 1 other identifier: RGH-MD-31
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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

Conditions

Bipolar Disorder

Keywords

Mania; Bipolar I Disorder; Acute Mania Associated with Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 3

Secondary Outcomes (1)

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3

  Baseline, 3 Weeks

Study Arms (2)

Cariprazine

EXPERIMENTAL

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

Drug: Cariprazine (RGH-188)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cariprazine (RGH-188) DRUG

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

Cariprazine

Placebo DRUG

Dose-matched placebo oral administration, once per day.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forest Laboratories: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (1)

For information regarding investigative sites, contact Forest Professional Affairs

St Louis, Missouri, 63045, United States

Location

Related Publications (2)

• 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.

  PMID: 31344528 DERIVED

• 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.

  PMID: 29017067 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

714-246-4500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Locations

US (1)