Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

NCT ID: NCT01190267

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-28
• Study Completion Date: 2013-10-07

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 generally safe and well tolerated in adolescents with schizophrenia. This is an extension of base study P05896 (NCT01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study P05897. Participants in this extension study will receive open-label asenapine for 26 weeks. Throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.

Conditions

Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Asenapine

All enrolled participants receive open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which is increased to 5.0 mg BID on Day 4 (dose can be increased earlier at the investigator's discretion). Asenapine dosing is flexible for the remainder of the 26-week open-label drug administration period, and can be adjusted to either 2.5 mg or 5.0 mg BID at the investigator's discretion, based on tolerability and/or symptomatology.

Group Type: EXPERIMENTAL

asenapine

Intervention Type: DRUG

asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID

Interventions

asenapine

asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID

Intervention Type: DRUG

Other Intervention Names

Saphris®, SCH 900274, Org 5222

Eligibility Criteria

Exclusion Criteria

• Must have completed the 8-week efficacy and safety trial (P05896 [NCT01190254]) and, according to the investigator's judgment, would benefit from long-term treatment.
• Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 [NCT01190254]), in the opinion of the investigator.

• A female participant must not be pregnant and must not have the intention to become pregnant during the trial.
• A participant must not be at imminent risk of self-harm or harm to others.
• A participant must not currently be under involuntary inpatient commitment.

• 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

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

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

2009-018038-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8274-021

Identifier Type: OTHER

Identifier Source: secondary_id

P05897

Identifier Type: -

Identifier Source: org_study_id