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

Schizophrenia Clinical Trial

Official title:

A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine Using Olanzapine as an Active Control in Subjects Diagnosed With Schizophrenia Who Completed Protocol P05688

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617200
• Other study ID #: P05689
• Secondary ID: 2010-018408-96
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2012
• Last updated: May 26, 2015
• Start date: December 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Asenapine
2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
• Placebo Asenapine
2.5 mg or 5 mg fast dissolving placebo asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
• Olanzapine
15 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
• Placebo Olanzapine
15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.

Locations

Country	Name	City	State
United States	Forest Investigative Site 2001	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight From Baseline to Day 182		Baseline (Day -1 of Short Term Trial) to Day 182 (Long-Term Extension)	Yes