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

August 25, 2010
October 23, 2013
September 2010
October 2013   (final data collection date for primary outcome measure)
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 ]
Safety and tolerability of long-term asenapine treatment in adolescents [ Time Frame: Through Week 26, plus a minimum of a 30-day follow up ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01190267 on ClinicalTrials.gov Archive Site
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Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897 AM2 EXT)
A 26-week, Multi-center, Open-label, Flexible Dose, Long-term 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 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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia, Paranoid
  • Schizophrenia, Disorganized
  • Schizophrenia, Undifferentiated
Drug: asenapine
asenapine 2.5 mg or 5 mg sublingually BID for 26 weeks
Other Name: Saphris®, SCH 900274, Org 5222
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.
Intervention: Drug: asenapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01190267
P05897, 2009-018038-12, MK-8274-021-0
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2013

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