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

NCT01190254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2024-05-21

Study results available
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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

Interventions

DRUG

asenapine 2.5 mg

asenapine 2.5 mg tablets for sublingual administration

DRUG

asenapine 5.0 mg

asenapine 5.0 mg tablets for sublingual administration

DRUG

placebo

asenapine-matched placebo tablets for sublingual administration

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-28
Primary Completion
2013-03-10
Completion
2013-04-01

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190254 on ClinicalTrials.gov