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

NCT00515879 | Completed Phase 3 Results DMC

• 2 other identifiers: R01MH078308R01MH075889
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Social Anxiety Disorder

Keywords

Generalized subtype

Outcome Measures

Primary Outcomes (2)

• Social Phobic Disorders Severity and Change Form

  Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).

  Measured at Months 3 (immediately after treatment)

• Liebowitz Social Anxiety Scale (LSAS)

  The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).

  Measured at Months 3

Secondary Outcomes (4)

• Social Phobia and Anxiety Inventory

  Measured at Months 3, 6, and 9 post-treatment

• Quality of Life Enjoyment and Satisfaction Questionnaire

  Measured at Months 3, 6, and 9 post-treatment

• Liebowitz Self-Rated Disability Scale

  Measured at Months 3, 6, and 9 post-treatment

• Range of Impaired Functioning Tool

  Measured at Months 3, 6, and 9 post-treatment

Study Arms (2)

CBT plus d-cycloserine

EXPERIMENTAL

Participants will receive cognitive behavioral therapy plus D-cycloserine

Drug: D-cycloserine; Behavioral: Cognitive behavioral therapy (CBT)

CBT plus placebo

PLACEBO COMPARATOR

Participants will receive cognitive behavioral therapy plus pill placebo

Behavioral: Cognitive behavioral therapy (CBT); Drug: Placebo

Interventions

D-cycloserine DRUG

50 mg

Also known as: Seromycin

CBT plus d-cycloserine

Cognitive behavioral therapy (CBT) BEHAVIORAL

CBT sessions aim to help participants become more comfortable with social situations.

CBT plus d-cycloserine; CBT plus placebo

Placebo DRUG

Same dosage as active pill

Also known as: Sugar pill

CBT plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• 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.

  PMID: 17227287 BACKGROUND

• 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.

  PMID: 17192764 BACKGROUND

• 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.

  PMID: 16520435 BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Interventions

Cycloserine; Cognitive Behavioral Therapy; Sugars

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Carbohydrates

Results Point of Contact

• Title: Dr. Stefan G. Hofmann, Ph.D., Professor of Psychology
• Organization: Boston University

shofmann@bu.edu

617 353 9233

Study Officials

• Stefan G. Hofmann, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Mark H. Pollack, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jasper A. Smits, PhD

  Southern Methodist University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2007
• First Posted: August 14, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 26, 2019
• Results First Posted: July 23, 2015

Record last verified: 2019-02

Locations

US (1)