Clinical trial NCT00515879: Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia
Official title: D-cycloserine Enhancement of Exposure in Social Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Social Anxiety Disorder
Keywords: Generalized subtype
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-08-14
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD.

Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 9-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with social situations. During 5 of the CBT sessions, participants will receive a pill containing either DCS or sugar (placebo). Assessment visits will include interviews, self-report questionnaires, and laboratory tests. These visits will occur at Weeks 1, 7, and 12 during treatment and at Months 3, 6, and 9 post-treatment.

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

Primary outcomes:
measure: Social Phobic Disorders Severity and Change Form
timeFrame: Measured at Months 3 (immediately after treatment)
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Measured at Months 3
Secondary outcomes:
measure: Social Phobia and Anxiety Inventory
timeFrame: Measured at Months 3, 6, and 9 post-treatment
measure: Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: Measured at Months 3, 6, and 9 post-treatment
measure: Liebowitz Self-Rated Disability Scale
timeFrame: Measured at Months 3, 6, and 9 post-treatment
measure: Range of Impaired Functioning Tool
timeFrame: Measured at Months 3, 6, and 9 post-treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Stefan G. Hofmann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Mark H. Pollack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Methodist University
name: Jasper A. Smits, PhD
role: STUDY_DIRECTOR
References:
citation: Hofmann SG, Pollack MH, Otto MW. Augmentation treatment of psychotherapy for anxiety disorders with D-cycloserine. CNS Drug Rev. 2006 Fall-Winter;12(3-4):208-17. doi: 10.1111/j.1527-3458.2006.00208.x.
citation: Otto MW, Basden SL, Leyro TM, McHugh RK, Hofmann SG. Clinical perspectives on the combination of D-cycloserine and cognitive-behavioral therapy for the treatment of anxiety disorders. CNS Spectr. 2007 Jan;12(1):51-6, 59-61. doi: 10.1017/s1092852900020526.
citation: Hofmann SG, Meuret AE, Smits JA, Simon NM, Pollack MH, Eisenmenger K, Shiekh M, Otto MW. Augmentation of exposure therapy with D-cycloserine for social anxiety disorder. Arch Gen Psychiatry. 2006 Mar;63(3):298-304. doi: 10.1001/archpsyc.63.3.298.