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Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896 AM2) (ADDRESS-96)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01190254
First received: August 25, 2010
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is designed to evaluate whether asenapine, which is a US FDA-approved acute treatment for 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.


Condition Intervention Phase
Schizophrenia, Paranoid
Schizophrenia, Disorganized
Schizophrenia, Undifferentiated
 Drug: asenapine
Drug: placebo BID
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Clinical Global Impression of Severity (CGI-S) score [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: September 2010
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine 2.5 mg BID
Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks.
 Drug: asenapine
asenapine 2.5 mg sublingually BID for 8 weeks
Other Name: Saphris®, SCH 900274, Org 5222
Experimental: Asenapine 5.0 mg BID
Participants receive active asenapine 2.5 mg tablets sublingually BID through the morning of their Day 4 visit. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8 week treatment period.
 Drug: asenapine
asenapine 5 mg sublingually BID for 8 weeks
Other Name: Saphris®, SCH 900274, Org 5222
Placebo Comparator: Placebo
Participants receive placebo asenapine tablets sublingually BID for 8 weeks.
 Drug: placebo BID
Asenapine-matched placebo sublingually BID for 8 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each participant must have schizophrenia, diagnosed, confirmed and reconfirmed 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.
  • 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).

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 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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01190254     History of Changes
Other Study ID Numbers: P05896, 2009-017971-10, MK-8274-020-0
Study First Received: August 25, 2010
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Asenapine
adolescents
schizophrenia
phase III
placebo-controlled

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia, Disorganized
Schizophrenia, Paranoid
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Asenapine
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013