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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder; Depression; Mania

Treatments: Drug: Cariprazine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03573297

RGH-MD-25

2017-000803-25 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 901 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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901 participants in 4 patient groups, including a placebo group

Double-Blind Cariprazine 3.0 mg/day

Experimental group

Description:

Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.

Treatment:

Drug: Cariprazine

Double-Blind Cariprazine 1.5 mg/day

Experimental group

Description:

Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.

Treatment:

Drug: Cariprazine

Double-Blind Placebo

Placebo Comparator group

Description:

Participants randomized to receive placebo QD for up to 39 weeks.

Treatment:

Drug: Placebo

Open Label Treatment

Experimental group

Description:

Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.

Treatment:

Drug: Cariprazine