Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior therapy in treating people with social anxiety disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University; Boston University Charles River Campus
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Cycloserine

Criteria

Inclusion Criteria:

• Meets DSM-IV criteria for generalized social anxiety disorder (GSAD)

• Total score of greater than or equal to 60 on the LSAS

• Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities

Exclusion Criteria:

• Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder

• Eating disorder within the 6 months prior to study entry

• History of organic brain syndrome, mental retardation, or other cognitive dysfunction

• Substance or alcohol abuse or dependence (other than nicotine) within the 6 months prior to study entry or inability to refrain from alcohol use during the acute period of study participation

• Post-traumatic stress disorder within 6 months prior to study entry; entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder

• Suicidal thoughts

• Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) within 2 weeks of study entry

• Significant personality dysfunction

• Serious medical illness or instability for which hospitalization may be likely within the next year