Protocol Number: 05-M-0198

Title:

Effect of D-cycloserine on Treatment of Social Phobia

Number:

05-M-0198

Summary:

This study examines whether an antibiotic, d-cycloserine (DCS), boosts the effectiveness of cognitive behavior therapy (CBT) for social anxiety. CBT has been shown to be effective for the treatment of social anxiety in children and adults, but even after treatment, approximately 40% may remain diagnosable. The antibiotic DCS has been shown to enhance the type of learning that is promoted by exposure therapy, a main component of CBT. This study will test whether DCS can improve the effectiveness of CBT for social anxiety.

All participants will receive 12 weekly CBT sessions. In addition to receiving the CBT, participants will be randomly assigned (similar to a coin toss) to receive either DCS or a placebo (sugar pill). The pill will be taken 1-2 hours prior to each of the 12 CBT sessions. The pill is taken only on the 12 therapy days.

Prior to receiving treatment, participants will be asked to:

- participate in interviews to assess diagnosis and how they are doing including mood, degree of nervousness and behavior

- have a physical examination, a urine test, and an electrocardiogram (EKG)

- undergo tests involving problem-solving and memory

- prepare and present a speech to a "virtual audience" using virtual reality goggles

- undergo functional magnetic resonance imaging (fMRI) while performing tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices

Those who have not improved by the end of the study will be offered standard antianxiety medication treatment for 1 to 3 months. If a participant does not wish to take medication, study clinicians will help him/her locate psychological care in the community. Participants will be asked to complete a follow-up assessment 3 months after their last CBT session.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA

1) Subjects over 7 yrs of age (preadolescents) and under 55 yrs of age.

2) Subjects medically healthy.

3) Able to give informed consent.

4) Not on psychotropic meds for a min. of 6 weeks for fluoxetine; a minimum of 1 week for p.r.n. benzodiazepines and beta blockers, and a minimum of 3 weeks for all other psychotropic meds.

5) Subjects diagnosed with DSM IV symptoms of social phobia, generalized or specific type.

EXCLUSION CRITERIA

1) Current major depressive disorder.

2) Lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, mental retardation, substance or alcohol dependence (other than nicotine); active suicidal ideation.

3) Current or lifetime history of a neurological disorder (other than tic disorders, febrile seizures of infancy), seizure disorder.

4) Any unstable medical condition.

5) Use of any psychoactive substance in the past 30 days.

Special Instructions:

Currently Not Provided

Keywords:

Cognitive

Behavioral

Adolescent

Therapy

Extinction

Recruitment Keyword(s):

Social Phobia

Condition(s):

Phobic Disorders

Anxiety

Social Phobia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: D-Cycloserine

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Alstrom JE, Nordlund CL, Persson G, Harding M, Ljungqvist C. Effects of four treatment methods on social phobic patients not suitable for insight-oriented psychotherapy. Acta Psychiatr Scand. 1984 Aug;70(2):97-110.

Butler G, Cullington A, Munby M, Amies P, Gelder M. Exposure and anxiety management in the treatment of social phobia. J Consult Clin Psychol. 1984 Aug;52(4):642-50. No abstract available.

D'Souza DC, Gil R, Cassello K, Morrissey K, Abi-Saab D, White J, Sturwold R, Bennett A, Karper LP, Zuzarte E, Charney DS, Krystal JH. IV glycine and oral D-cycloserine effects on plasma and CSF amino acids in healthy humans. Biol Psychiatry. 2000 Mar 1;47(5):450-62.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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