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

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

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Key information

Conditions

Bipolar I Disorder Behavior Behavioral Symptoms Depression Mania Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas /ID# 232777, Burgas, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cariprazine

Drug

Cariprazine capsules, oral administration, once daily

Placebo

Drug

Matching placebo capsules, oral administration, once daily

Primary outcomes

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

Time frame: From Week 16 to Week 55
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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jun 29, 2018
Registry last updated: Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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