Treatment for Pediatric Bipolar Disorder

• Conditions: Acute Manic or Mixed Episodes Associated with Bipolar I Disorder; MedDRA version: 14.0Level: LLTClassification code 10068455Term: Bipolar I disorder, hypomanicSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-022648-19-Outside-EU/EEA
• Lead Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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 before trial participation;
2. Each subject must have completed the 3-week (P06107) efficacy and safety trial and, according to the investigator’s judgment, may benefit from long-term treatment;
3. Each subject must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in trial P06107 in the opinion of the investigator;
4. Each subject must be =12 years and =18 years of age; A subject may be of either sex, and of any race/ethnicity;
5. Each subject must be a male, or a female who is not of childbearing potential (eg, surgically sterile) or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception. If a female subject of childbearing potential, must agree to use a medically
accepted method of contraception while receiving protocol specified medication and for 1 month after stopping the medication;
6. Each subject must have a caregiver, or an identified responsible person, living with the subject, 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;

Refer to protocol for complete list

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

Exclusion Criteria

1. The subject has a positive urine pregnancy test at Baseline, or the intention to become pregnant during the course of the trial;
2. The subject is 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. The subject is under involuntary inpatient commitment;
4. A subject has known serological evidence of human immunodeficiencyvirus (HIV) antibody.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified