Omega-3 and Therapy Study for Childhood Bipolar Disorder- Not Otherwise Specified

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Bipolar Disorder
Interventions
DRUG

Omega-3 Supplementation

The Ω3 group will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3) two times daily for a total daily dose of 2000 mg Ω3 (1400 mg EPA: 200 mg DHA; 400 other Ω3). The placebo group will receive two capsules two times daily matched for odor and appearance with the active intervention.

BEHAVIORAL

Psychoeducational Psychotherapy (PEP)

Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. The importance of separating symptoms from the individual is emphasized. The family is offered support, validation, and recognition for their own difficult experiences in living with the child's mood disorder. Family members are taught that patients are particularly vulnerable to stress and tension; thus, therapists work with families to reduce the level of stress and tension in their homes. Improvement of communication, problem solving and coping strategies can lead to restoration of hope for recovery and decrease family dysfunction. Goals include strengthening the parent-child bond and helping children and parents feel competent to manage depression now and in future recurrences.

OTHER

Placebo

The placebo group will receive active monitoring (no IF-PEP) and two capsules two times daily matched for odor and appearance with the active intervention.

Trial Locations (1)

43210

Ohio State University Medical Center- Harding Hospital, Columbus

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

L. Eugene Arnold

OTHER

NCT01507753 - Omega-3 and Therapy Study for Childhood Bipolar Disorder- Not Otherwise Specified | Biotech Hunter | Biotech Hunter