Phase 3 N=169 Randomized Double-blind Treatment

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

Social Anxiety Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00515879 ↗

Enrolled (actual)

169

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Social Phobic Disorders Severity and Change Form — 2.68; 2.95 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: D-cycloserine (Drug); Cognitive behavioral therapy (CBT) (Behavioral); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston University Charles River Campus
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Social Phobic Disorders Severity and Change Form	2.68; 2.95	—
PRIMARY Liebowitz Social Anxiety Scale (LSAS)	39.19; 42.44	—
SECONDARY Social Phobia and Anxiety Inventory	71.08; 73.74; 69.64; 71.97; 67.67; 67.74	—
SECONDARY Quality of Life Enjoyment and Satisfaction Questionnaire	67.77; 67.44; 66.32; 67.44; 67.08; 69.58	—
SECONDARY Liebowitz Self-Rated Disability Scale	15.6117; 14.0303; 15.5283; 14.4977; 15.3269; 14.3130	—
SECONDARY Range of Impaired Functioning Tool	8.5256; 8.6667; 8.6143; 8.5430; 8.6232; 7.7458	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00515879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.