Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

Phase 3

Completed

Brief Summary: Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

Recruitment & Eligibility

Inclusion Criteria

Provide written informed consent and is 18 to 75 years of age inclusive.
Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
Has a lifetime history of at least one bipolar manic or mixed manic episode.
Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria

Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than Bipolar I Disorder).
Hospitalization for a manic or mixed episode within the past two months.
Used investigational compound within past 6 months.
Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Lurasidone 20-120 mg flexible dose	Lurasidone	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)	Baseline to week 6	MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)	Baseline to week 6	CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score	Baseline to week 6	SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.

Locations (75): Clinical Innovations, Inc.
🇺🇸
Costa Mesa, California, United States
Clinical Innovations Inc.
🇺🇸
Riverside, California, United States
Artemis Institute for Clinical Research
🇺🇸
San Diego, California, United States
Sharp Mesa Vista Hospital
🇺🇸
San Diego, California, United States
Clinical Innovations inc.
🇺🇸
Santa Ana, California, United States
Collaborative Neuroscience Network
🇺🇸
Torrance, California, United States
Colorado Clinical Trials Inc.
🇺🇸
Highlands Ranch, Colorado, United States
Accurate Clinical Trials
🇺🇸
Kissimmee, Florida, United States
Clinical Neuroscience Solutions Inc.
🇺🇸
Orlando, Florida, United States
Northwest Behavioral Research Center
🇺🇸
Roswell, Georgia, United States
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Clinical Innovations, Inc.
🇺🇸Costa Mesa, California, United States