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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01190267
First received: August 25, 2010
Last updated: March 26, 2013
Last verified: March 2013
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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:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Asenapine
U.S. FDA Resources
Further study details as provided by Merck:
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 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| 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: | March 26, 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 May 19, 2013