Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897 AM2 EXT) (ADDRESS-97)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01190267
First received: August 25, 2010
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

This study is designed to evaluate whether asenapine, which is a US FDA-approved acute treatment for schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia. This is an extension of study to P05896, which means participants must have completed participation in the 8-week study in order to qualify for this study. Participants 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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Long Term Safety and Tolerability Associated with Extended Asenapine Treatment in Adolescents [ Time Frame: Through Week 26, plus a minimum of a 30-day follow up ] [ Designated as safety issue: Yes ]

Enrollment: 204
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine
Participants who have previously completed Trial P05896 may enter this extension trial and receive open-label active asenapine 2.5 mg tablets or 5 mg tablets sublingually twice weekly (BID) for 26 weeks. The dose can be adjusted at the investigator's discretion based on tolerability and/or symptomatology.
Drug: asenapine
asenapine 2.5 mg or 5 mg sublingually BID for 26 weeks
Other Name: Saphris®, SCH 900274, Org 5222

  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 be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week trial (P05896) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met.
  • Must have completed the 8-week efficacy and safety trial (P05896) 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), in the opinion of the investigator.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01190267     History of Changes
Other Study ID Numbers: P05897, 2009-018038-12, MK-8274-021-0
Study First Received: August 25, 2010
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

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 July 26, 2014