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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01190254
First received: August 25, 2010
Last updated: April 9, 2013
Last verified: April 2013

August 25, 2010
April 9, 2013
September 2010
March 2013   (final data collection date for primary outcome measure)
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
Positive and Negative Syndrome Scale (PANSS) total score, Change from baseline [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01190254 on ClinicalTrials.gov Archive Site
Change from baseline in Clinical Global Impression of Severity (CGI-S) score [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity of subjects' illness, change from baseline [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
  • Total PANSS 30% responders, proportion [ Time Frame: Day 56/Endpoint ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896 AM2)
An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia, Paranoid
  • Schizophrenia, Disorganized
  • Schizophrenia, Undifferentiated
  • Drug: asenapine
    asenapine 2.5 mg sublingually BID for 8 weeks
    Other Name: Saphris®, SCH 900274, Org 5222
  • Drug: asenapine
    asenapine 5 mg sublingually BID for 8 weeks
    Other Name: Saphris®, SCH 900274, Org 5222
  • Drug: placebo BID
    Asenapine-matched placebo sublingually BID for 8 weeks
  • Experimental: Asenapine 2.5 mg BID
    Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks.
    Intervention: Drug: asenapine
  • 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.
    Intervention: Drug: asenapine
  • Placebo Comparator: Placebo
    Participants receive placebo asenapine tablets sublingually BID for 8 weeks.
    Intervention: Drug: placebo BID
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
April 2013
March 2013   (final data collection date for primary outcome measure)

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).
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01190254
P05896, 2009-017971-10, MK-8274-020-0
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP