6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)

NCT ID: NCT01098110

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-25
• Study Completion Date: 2014-04-14

Brief Summary

A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Asenapine 5 mg BID

Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.

Group Type: EXPERIMENTAL

Asenapine 5 mg

Intervention Type: DRUG

Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.

Asenapine 10 mg BID

Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.

Group Type: EXPERIMENTAL

Asenapine 5 mg

Intervention Type: DRUG

Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.

Asenapine 10 mg

Intervention Type: DRUG

Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.

Placebo BID

Participants received matching placebo BID for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A matching placebo of asenapine sublingual tablet not containing asenapine

Interventions

Asenapine 5 mg

Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.

Intervention Type: DRUG

Asenapine 10 mg

Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.

Intervention Type: DRUG

Placebo

A matching placebo of asenapine sublingual tablet not containing asenapine

Intervention Type: DRUG

Other Intervention Names

SCH 900274; SCH 900274

Eligibility Criteria

Inclusion Criteria

• current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or undifferentiated (295.90) subtype
• minimum Positive and Negative Syndrome Scale (PANSS) total score of 60 at screening and Baseline.
• participant had a score of at least 4 in two or more of 5 items in the positive subscale of the PANSS at Screening and Baseline.
• participant confirmed by the investigator to be experiencing an acute exacerbation of schizophrenia as evidenced by ALL of the following:

• at the screening test, the duration of the current episode was no more than 2 months;
• current symptoms represented a dramatic and substantial change compared to the participant's symptomatic state prior to the emergence of the current episode;
• participant was in need of changing medication or dosage to treat newly appeared or worsened positive symptoms.
• participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Baseline;
• responded positively to an antipsychotic medication in a prior episode.
• discontinued the use of all prohibited concomitant medications, with last dose taken no later than the evening prior to the baseline visit (For depot neuroleptic, discontinuation must have occurred more than 3 months prior to randomization).
• participants must agree to inpatient status for screening period and for up to 42 days of dosing and, for out-patient phase, had a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) whom the investigator accepts and who has agreed to provide support to the participant to ensure compliance with study treatment, out-patient visits, and protocol procedures.

Exclusion Criteria

• not be treatment-refractory defined by the following criteria: (1) had been treated with at least two different atypical anti-psychotic agents at dosages equivalent to or greater than 600 mg/day of chlorpromazine (12 mg /day of haloperidol) for more than 4 weeks, each without clinical response, or (2) has received clozapine for 12 weeks immediately preceding the screening.
• not have received treatment with 3 or more antipsychotic drugs, or dose-equivalents higher than 18 mg/day of haloperidol (equivalent 900 mg/day of chlorpromazine) within one month prior to randomization.
• not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophreniform disorder, or schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission
• not have a concurrent psychiatric disorder other than schizophrenia coded on Axis I; not have a primary diagnosis other than schizophrenia
• not have had a known diagnosis of borderline personality disorder, mental retardation or organic brain disorder.
• not have a 20% or greater decrease in PANSS total score from screening to baseline
• not have an imminent risk of self-harm or harm to others, in the investigator's opinion.
• not have a substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
• not be currently under involuntary in-patient confinement.
• not been previously treated with asenapine.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Kinoshita T, Bai YM, Kim JH, Miyake M, Oshima N. Efficacy and safety of asenapine in Asian patients with an acute exacerbation of schizophrenia: a multicentre, randomized, double-blind, 6-week, placebo-controlled study. Psychopharmacology (Berl). 2016 Jul;233(14):2663-74. doi: 10.1007/s00213-016-4295-9. Epub 2016 Jun 8.

Reference Type: RESULT

PMID: 27271087 (View on PubMed)

Other Identifiers

P06124

Identifier Type: -

Identifier Source: org_study_id