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

NCT01190254 | Completed Phase 3 Results DMC

• 4 other identifiers: P058962009-017971-10MK-8274-020CTRI/2011/07/001909
• Study Type: interventional
• Target: 306
• Locations: 0 countries
• Sites: N/A

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

Keywords

Asenapine; adolescents; schizophrenia; phase IIIb; placebo-controlled

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56

  The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.

  Baseline and Day 56

Secondary Outcomes (18)

• Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56

  Baseline and Day 56

• Change From Baseline in PANSS Positive Subscale Score at Day 56

  Baseline and Day 56

• Change From Baseline in PANSS Negative Subscale Score at Day 56

  Baseline and Day 56

• Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56

  Baseline and Day 56

• Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56

  Baseline and Day 56

Study Arms (3)

Asenapine 2.5 mg BID

EXPERIMENTAL

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

Drug: asenapine 2.5 mg

Asenapine 5.0 mg BID

EXPERIMENTAL

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.

Drug: asenapine 2.5 mg; Drug: asenapine 5.0 mg

Placebo

PLACEBO COMPARATOR

Participants receive placebo asenapine tablets sublingually BID for 8 weeks.

Drug: placebo

Interventions

asenapine 2.5 mg DRUG

asenapine 2.5 mg tablets for sublingual administration

Also known as: Saphris®, SCH 900274, Org 5222

Asenapine 2.5 mg BID; Asenapine 5.0 mg BID

asenapine 5.0 mg DRUG

asenapine 5.0 mg tablets for sublingual administration

Also known as: Saphris®, SCH 900274, Org 5222

Asenapine 5.0 mg BID

placebo DRUG

asenapine-matched placebo tablets for sublingual administration

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 26091193 RESULT

MeSH Terms

Conditions

Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia; Disorders of Sex Development

Interventions

asenapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: September 28, 2010
• Primary Completion: March 10, 2013
• Study Completion: April 1, 2013
• Last Updated: May 21, 2024
• Results First Posted: June 6, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share