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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01190267

First received: August 25, 2010

Last updated: March 26, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	August 25, 2010
Last Updated Date	March 26, 2013
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 27, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: August 25, 2010)	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 ]
Change History	Complete list of historical versions of study NCT01190267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897 AM2 EXT)
Official Title ^ICMJE	A 26-week, Multi-center, Open-label, Flexible Dose, Long-term Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Schizophrenia, Paranoid Schizophrenia, Disorganized Schizophrenia, Undifferentiated
Intervention ^ICMJE	Drug: asenapine asenapine 2.5 mg or 5 mg sublingually BID for 26 weeks Other Name: Saphris®, SCH 900274, Org 5222
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	150
Estimated Completion Date	September 2013
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	12 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01190267
Other Study ID Numbers ^ICMJE	P05897, 2009-018038-12, MK-8274-021-0
Has Data Monitoring Committee	Yes
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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