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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: Asenapine; Drug: Placebo Olanzapine; Drug: Placebo Asenapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01617200

2010-018408-96 (EudraCT Number)

P05689

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 4 patient groups

Asenapine 2.5 mg BID

Experimental group

Treatment:

Drug: Placebo Olanzapine

Drug: Asenapine

Asenapine 5 mg BID

Experimental group

Treatment:

Drug: Placebo Olanzapine

Drug: Asenapine

Olanzapine 15 mg QD

Active Comparator group

Treatment:

Drug: Placebo Asenapine

Drug: Placebo Olanzapine

Drug: Olanzapine

Placebo switched to Asenapine 2.5 mg BID

Experimental group

Treatment:

Drug: Placebo Olanzapine

Drug: Asenapine