A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

AbbVie901 enrolled

Overview

1\) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

901

Conditions

Bipolar I Disorder Mania Depression

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria: * Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior); * OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel). Exclusion Criteria: * Four or more episodes of a mood disturbance within the 12 months before Visit 1; * Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.

Locations (108)

Woodland International Research Group /ID# 232932

Little Rock, Arkansas, United States

Woodland Research Northwest, LLC /ID# 232982

Rogers, Arkansas, United States

California Pharmaceutical Research Institute Inc. /ID# 232745

Anaheim, California, United States

Advanced Research Center /ID# 233120

Anaheim, California, United States

CI Trials /ID# 232642

Bellflower, California, United States

Outcomes

Primary Outcomes

Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period

Relapse was defined as the occurrence of any 1 of the following: * Young Mania Rating Score (YMRS) total score ≥ 17 (range 0-60; higher score indicates a worse outcome); * Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20 (range 0-60; higher score indicates more depressive symptoms); * Clinical Global Impression-Improvement scale (CGI-S) ≥ 4 (range from 1 \[normal, not at all ill\] to 7 \[extremely ill\]); * Initiation of additional psychiatric medication; * Psychiatric hospitalization; * Exacerbation of illness as judged by clinical impression of the Investigator. Time to first relapse (days) was calculated as the date of the first relapse - the date of randomization + 1. Participants who did not meet the relapse criteria were considered censored at the time of completion or discontinuation from the Double-Blind Treatment Period (DBTP) of the study. Percentiles (95% Confidence Intervals \[CI\]) are based on Kaplan-Meier estimates.

Time frame: From Week 16 to Week 55