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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar I Disorder, Mania, Depression

In brief

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

Key facts

Study ID

NCT03573297

Run by

AbbVie

People needed

901

Starts

2018-06-15

Expected to finish

2022-09-05

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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
• Synexus Clinical Research US Inc. /ID# 232743 — Cerritos, California, United States
• ATP Clinical Research, Inc /ID# 232979 — Costa Mesa, California, United States
• ProScience Research Group /ID# 232945 — Culver City, California, United States
• Collaborative Neuroscience Research - Orange County /ID# 233077 — Garden Grove, California, United States
• Behavioral Research Specialists, LLC /ID# 232980 — Glendale, California, United States
• Omega Clinical Trials LLC /ID# 233150 — La Habra, California, United States
• Synergy San Diego /ID# 232740 — Lemon Grove, California, United States
• Alliance for Research - Long Beach /ID# 232926 — Long Beach, California, United States
• NRC Research Institute /ID# 232741 — Orange, California, United States
• CNRI-San Diego /ID# 232748 — San Diego, California, United States
• Artemis Institute for Clinical Research /ID# 233151 — San Marcos, California, United States
• Artemis Institute for Clinical Research /ID# 233152 — San Marcos, California, United States
• Collaborative Neuroscience Research LLC /ID# 232750 — Torrance, California, United States
• Duplicate_MCB Clinical Research Centers LLC /ID# 232838 — Colorado Springs, Colorado, United States
• Velocity Clinical Research - Hallandale Beach /ID# 232647 — Hallandale, Florida, United States
• Research Centers of America - Hollywood FL /ID# 232649 — Hollywood, Florida, United States
• CNS Healthcare - Jacksonville /ID# 233160 — Jacksonville, Florida, United States
• Meridien Research /ID# 232941 — Maitland, Florida, United States
• Miami Lakes Medical Research /ID# 232826 — Miami Lakes, Florida, United States
• University of South Florida /ID# 233093 — Tampa, Florida, United States
• Woodland International Research Group /ID# 232932 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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