Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)

NCT ID: NCT01190254

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-28
• Study Completion Date: 2013-04-01

Brief Summary

This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in adolescents with schizophrenia. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each participant at various times to assess the efficacy and safety of the study treatment. The primary objective of the trial is to demonstrate significant superiority of at least one asenapine dose to placebo, as measured by the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.

Conditions

Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated

Study Design

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

Study Groups

Asenapine 2.5 mg BID

Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks.

Group Type: EXPERIMENTAL

asenapine 2.5 mg

Intervention Type: DRUG

asenapine 2.5 mg tablets for sublingual administration

Asenapine 5.0 mg BID

Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period.

Group Type: EXPERIMENTAL

asenapine 2.5 mg

Intervention Type: DRUG

asenapine 2.5 mg tablets for sublingual administration

asenapine 5.0 mg

Intervention Type: DRUG

asenapine 5.0 mg tablets for sublingual administration

Placebo

Participants receive placebo asenapine tablets sublingually BID for 8 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

asenapine-matched placebo tablets for sublingual administration

Interventions

asenapine 2.5 mg

asenapine 2.5 mg tablets for sublingual administration

Intervention Type: DRUG

asenapine 5.0 mg

asenapine 5.0 mg tablets for sublingual administration

Intervention Type: DRUG

placebo

asenapine-matched placebo tablets for sublingual administration

Intervention Type: DRUG

Other Intervention Names

Saphris®, SCH 900274, Org 5222; Saphris®, SCH 900274, Org 5222

Eligibility Criteria

Inclusion Criteria

• Each participant must have schizophrenia, diagnosed and confirmed by board-eligible or board certified psychiatrists with at least two years of specialization in pediatric/adolescent psychiatric medicine.
• Each participant must be ≥12 years of age and <18 years of age.
• Each participant must have a minimum PANSS total score of 80 at Screening and Baseline.
• Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution) at Screening and Baseline.
• Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline.
• Each participant must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers) prior to Baseline.
• Each participant must agree not to begin formal, structured psychotherapy during the trial.

Exclusion Criteria

• A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with "continuous," "single episode in partial remission," or "single episode in full remission" course specifiers.
• A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.
• A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder.
• A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria for substance abuse or dependence (excluding nicotine).
• A participant must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse.
• A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Findling RL, Landbloom RP, Mackle M, Pallozzi W, Braat S, Hundt C, Wamboldt MZ, Mathews M. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):384-96. doi: 10.1089/cap.2015.0027.

Reference Type: RESULT

PMID: 26091193 (View on PubMed)

Other Identifiers

2009-017971-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8274-020

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2011/07/001909

Identifier Type: OTHER

Identifier Source: secondary_id

P05896

Identifier Type: -

Identifier Source: org_study_id