A randomized controlled trial of patients with obsessive-compulsive disorder: A functional magnetic resonance imaging study

UMIN ID: UMIN000001726

Registered date:22/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: obsessive-compulsive disorder(OCD)
• Date of first enrollment: 2001/08/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Fluvoxamine, up to a dose of 200mg/day, Autogenic Training (a psychological placebo), once a week for 12 weeks
pill placebo behavior therapy, once a week for 12 weeks
pill placebo Autogenic Training (a psychological placebo), once a week for 12 weeks

Outcome(s)

• Primary Outcome: Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (after the 12-week treatment) functional activation maps (before and after treatment) Neuropsychological tests (attention, executive function, memory)
• Secondary Outcome: Hamilton Depressive Rating Scale (HDRS) State-Trait Anxiety Inventory (STAI) (after the 12-week treatment)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: comorbid axis I diagnosis neurological disorder head injury serious medical condition history of drug/alcohol addiction a total y-BOCS score lower than 16 a HDRS score more than 18 points a total IQ of less than 80

Related Information

• Primary Sponsor: Kyushu University
• Source(s) of Monetary Support: the Japanese Ministry of Education, Culture, Sports, Science and Technology