Clinical trial NCT01058096: Safety and Efficacy of Cariprazine for Mania
Official title: A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Mania
Keywords: Acute Mania
Bipolar I Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2010-01-28
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided informed consent prior to any study specific procedures
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
* Voluntarily hospitalized for current manic episode
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months

Primary outcomes:
measure: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
timeFrame: Baseline, Week 3
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
timeFrame: Baseline, Week 3
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Forest Investigative Site 004
state: California
city: Riverside
country: United States
facility: Forest Investigative Site 005
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 007
state: California
city: Chicago
country: United States
facility: Forest Investigative Site 009
state: Illinois
city: Lake Charles
country: United States
facility: Forest Investigative Site 006
state: Louisiana
city: Flowood
country: United States
facility: Forest Investigative Site 001
state: Mississippi
city: Creve Couer
country: United States
facility: Forest Investigative Site 003
state: Missouri
city: Cleveland
country: United States
facility: Forest Investigative Site 008
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 010
state: Oklahoma
city: Houston
country: United States
facility: Forest Investigative Site 002
state: Texas
city: Vijayawada
country: India
facility: Forest Investigative Site 106
state: Andhra Pradesh
city: Vizag
country: India
facility: Forest Investigative Site 112
state: Andhra Pradesh
city: Varanasi
country: India
facility: Forest Investigator Site 108
state: Durgakund
city: Ahmedabad
country: India
facility: Forest Investigative Site 103
state: Gujarat
city: Ahmedabad
country: India
facility: Forest Investigative Site 120
state: Gujarat
city: Bangalore
country: India
facility: Forest Investigative Site 105
state: Karnataka
city: Bangalore
country: India
facility: Forest Investigative Site 107
state: Karnataka
city: Mangalore
country: India
facility: Forest Investigative Site 118
state: Karnataka
city: Mangalore
country: India
facility: Forest Investigative Site 113
state: Karnataka
city: Manipal
country: India
facility: Forest Investigative Site 115
state: Karnataka
city: Mysore
country: India
facility: Forest Investigative Site 114
state: Karnataka
city: Aurangabad
country: India
facility: Forest Investigative Site 101
state: Maharashtra
city: Nasik
country: India
facility: Forest Investigative Site 110
state: Maharashtra
city: Pune
country: India
facility: Forest Investigative Site 111
state: Maharashtra
city: Pune
country: India
facility: Forest Investigative Site 104
state: Maharashtra
city: Chennai
country: India
facility: Forest Investigative Site 121
state: Tamilnadu
city: Kanpur
country: India
facility: Forest Investigative Site 109
state: Uttar Pradesh
city: Lucknow
country: India
facility: Forest Investigative Site 119
state: Uttar Pradesh
Study officials:
affiliation: Forest Laboratories
name: Elizabeth Diaz, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.