A 26-week, multi-center, open-label, flexible dose, long-term safety trial of asenapine in adolescent subjects with schizophrenia - Gemini-S26
- Conditions
- SchizophreniaMedDRA version: 12.1 Level: LLT Classification code 10039626 Term: Schizophrenia
- Registration Number
- EUCTR2009-018038-12-RO
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 204
The subject must fulfill ALL the criteria listed below for entry.
1. Each subject’s parent(s) or legal representative must be willing and able to provide written informed consent for the trial and each subject must indicate assent.
2. Each subject must have completed the 8-week (P05896) efficacy and safety trial, still must be younger than 18 years of age, and, according to the investigator’s judgment, would benefit from long-term treatment;
3. Each subject 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;
4. Each subject must have a caregiver (see Section 7.6.1 of the protocol, Procedure 3) who is considered reliable by the investigator and who has agreed to provide support to the subject to ensure compliance with trial treatment, outpatient visits, and protocol procedures. The caregiver must be living with the subject and can be the subject’s parent(s) or legal representative.
5. Each female subject of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception while receiving protocol specified medication and for 1 month after stopping the medication should she become sexually active while participating in the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
The subject must fulfill ALL the criteria listed below for entry.
1. A female subject must not have a positive urine pregnancy test prior to dosing on Day 1, and must not have the intention to become pregnant during the course of the trial.
2. A subject must not be at imminent risk of self-harm or harm to others, in the investigator’s opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).
3. A subject must not currently be under involuntary inpatient commitment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method