Phase 3
N=356
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT01284517 ↗Enrolled (actual)
356
Serious AEs
2.3%
Results posted
Oct 2013
Primary outcome: Primary: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) — -11.8; -10.4 units on a scale — p=0.176
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lurasidone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) |
-11.8; -10.4 | 0.176 |
| SECONDARY Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) |
-1.36; -1.13 | 0.095 |
| SECONDARY Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score |
-5.4; -5.4 | 0.992 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01284517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.