Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)

NCT00156091 | Completed Phase 3 DMC

• 3 other identifiers: P05784Hera;41512
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. The clinical development of asenapine, as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. Its fast dissolving formulation may further add to treatment compliance. While various titration schedules have been used in previous studies, dose increases at 5 mg BID up to 10 mg BID have been well tolerated. Therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual clinical practice in a long-term 52-week extension trial.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• To assess long-term safety including overall symptoms (AEs; SAEs); Vital signs; ISST; EPS; and maintenance of effect; for asenapine with haloperidol control.

  Weeks 1;2; 4; 8; 12; 16; 24; 32; 40; 52 (Endpoint)

• Quality of Life and Patient Functionality (QLS; Q-LES-Q and PETIT)

  Weeks 16; 32; 52(Endpoint)

Secondary Outcomes (6)

• Pregnancy tests; Lab tests

  Weeks 8; 16; 32; 52 (Endpoint)

• Physical exams

  Week 12; 24; 52 (Endpoint)

• Neurocognition and cognitive functioning

  Weeks 24 and 52 (Endpoint)

• Weight and abdominal girth

  Weeks 4;8;12; 16; 24; 32;40;52(Endpoint)

• ECGs

  Weeks 2;4;8;24;52(Endpoint)

Study Arms (3)

1

ACTIVE COMPARATOR

Olanzapine 20 mg QD

Drug: Olanzapine

2

EXPERIMENTAL

Asenapine 5 or 10 mg BID

Drug: Asenapine

3

OTHER

Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041021 or 041022 asenapine trials, were randomized (double-blind) Into the long-term 041512 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52 week trial.

Other: Placebo

Interventions

Olanzapine DRUG

5- 20 mg QD

1

Asenapine DRUG

5 or 10 mg BID

2

Placebo OTHER

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed the short-term trial ( 041021 or 021022)
• Sign a written informed consent for the 041512 trial.
• Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

You may not qualify if:

• CGI-S score of greater or equal to 6 ( severely psychotic)
• Occurrence(s) of AE or other clinically significant findings that would prohibit their continuation

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine; asenapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: February 16, 2022

Record last verified: 2022-02