Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689)

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo Asenapine; Drug: Asenapine; Drug: Placebo Olanzapine; Drug: Olanzapine

• Registration Number: NCT01617200
• Lead Sponsor: Forest Laboratories

Brief Summary

Participants who have completed the 6-week trial P05688 can be screened for eligibility for this 26-week extension study in which they will continue treatment. The purpose of this trial is to evaluate the long-term safety of 2.5 and 5 mg asenapine administered sublingually twice daily (BID) in schizophrenia participants. Olanzapine administered 15 mg orally once daily (QD) is used as an active control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Study Start: 2012-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Completed the short-term trial P05688, and judged by the investigator likely to benefit from continued treatment

Exclusion Criteria

• Occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the participant's continuation into the long-term extension
• Clinical Global Impression-Severity of Illness (CGI-S) score of ≥6 (severely psychotic) at Baseline
• Newly diagnosed or discovered psychiatric condition that would have excluded the participant from participation in the short-term trial P05688

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine 15 mg QD	Placebo Asenapine	-
Asenapine 2.5 mg BID	Placebo Olanzapine	-
Asenapine 5 mg BID	Placebo Olanzapine	-
Olanzapine 15 mg QD	Placebo Olanzapine	-
Placebo switched to Asenapine 2.5 mg BID	Placebo Olanzapine	-
Asenapine 2.5 mg BID	Asenapine	-
Olanzapine 15 mg QD	Olanzapine	-
Asenapine 5 mg BID	Asenapine	-
Placebo switched to Asenapine 2.5 mg BID	Asenapine	-

Primary Outcome Measures

Name	Time	Method
Change in Weight From Baseline to Day 182	Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension)

Trial Locations

Locations (1)

Forest Investigative Site 2001; 🇺🇸 Austin, Texas, United States