Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947)

NCT00151424 | Completed Phase 3 DMC

• 3 other identifiers: P05947Hera41022
• Study Type: interventional
• Target: 277
• 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. Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (6-week double-blind or last assessment after baseline) from baseline

  A 30-item, clinician rated instrument for assessing the symptoms of schizophrenia. Ratings for each item could range from 1 (absent) to 7 (extreme).

  Screen, baseline, days 4, 7, 14, 21, 28, 35, 42

Secondary Outcomes (14)

• Changes in PANSS subscale and Marder factor score Clinical Global Impression-Severity of Illness (CGI-S) scores

  Screen, baseline, Days 4,7,14,21,28,35,42

• Clinical Global Impression Improvement (CGI-I) scores

  Days 4,7,14,21,28,35,42

• Neurocognition and cognitive functioning

  Baseline , day 42

• Anxiety

  Baseline, day 42

• Suicidal thinking

  Baseline, day 42

Study Arms (3)

1

EXPERIMENTAL

asenapine 5-10mg BID

Drug: asenapine

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

3

ACTIVE COMPARATOR

olanzapine 10-20 mg QD

Drug: Olanzapine

Interventions

asenapine DRUG

Asenapine 5-10mgBID

1

Placebo DRUG

Matched against asenapine and olanzapine

2

Olanzapine DRUG

10-20 mg QD

3

Eligibility Criteria

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

You may qualify if:

• Currently suffering from an acute exacerbation of schizophrenia.

You may not qualify if:

• Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Szegedi A, Verweij P, van Duijnhoven W, Mackle M, Cazorla P, Fennema H. Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics. J Clin Psychiatry. 2012 Dec;73(12):1533-40. doi: 10.4088/JCP.11r07596.

  PMID: 23290326 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

asenapine; Olanzapine

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 9, 2005
• Study Start: February 15, 2005
• Primary Completion: January 6, 2006
• Study Completion: February 6, 2006
• Last Updated: August 15, 2024

Record last verified: 2022-02