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Clinical Trial: Effect of D-Cycloserine on Treatment in Social Anxiety
This study is currently recruiting patients.
Verified by National Institutes of Health Clinical Center (CC) July 5, 2005
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Purpose
This study will examine the effects of D-Cycloserine (DCS) in patients undergoing cognitive behavioral therapy for social anxiety. Current treatment for social anxiety consists of medication (often with SSRIs, such as Prozac, Zoloft, Cipramil, or Lexapro) and behavioral therapy. Although patients often benefit from these treatments, most continue to have some residual symptoms, if not full-blown anxiety disorders. This study will test whether DCS might alleviate patients'''' fear of social scrutiny, which is a basic component of social phobia.
Medically healthy people with symptoms of social anxiety who are over 7 and under 55 years of age and who are not currently taking any psychiatric medicines may be eligible for this study. Candidates are screened with a psychiatric interview, physical examination, electrocardiogram, and blood and urine tests.
Participants have 12 therapy sessions with a psychologist. Beginning with the fifth session and for all remaining sessions, they are given a pill that is either DCS or placebo. In addition, participants undergo the following procedures:
-Psychological and psychobiological experiments: These tests are done in 2-hour sessions before starting treatment, in the middle of the study, and after its completion. The subject prepares a speech and then delivers it in front of a virtual audience (in a virtual reality environment) that that is seen on goggles that are connected to a computer. The subject''''s heart rate, respiration and startle response are recorded before and after the speech. Breathing, skin conductance response, eye movements, and the size of eye blinks may also be measured using small electrodes placed on the skin. Response to air puffs to the neck and loud sounds may also be measured.
-Attentional bias test: Subjects press a computer key in response to a stimulus while looking at a series of facial expressions on a computer monitor. This test is done at the beginning and end of treatment.
-Symptoms ratings scales: Subjects are evaluated with clinician- and self-rated scales for social anxiety and phobia before and after treatment.
At the end of the study participants may be offered from 1 to 3 months of free treatment with standard medications for anxiety, including SSRIs. They are then referred to community resources for mental health treatment.
| Intervention | Phase |
|---|---|
| Drug: D-Cycloserine | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy
Official Title: Effect of D-Cycloserine on the Treatment in Social Phobia
Further Study Details:
Expected Total Enrollment: 104
Study start: August 5, 2005
Social phobia afflicts between 3%-15% of the US population. As such, it is a particularly common debilitating psychiatric disorder. Like many anxiety disorders, social phobia typically arises during adolescence. Treatment has consisted of medication or cognitive behavioral therapy (CBT). Selective Serotonin Reuptake Inhibitors (SSRIs) represent the first-line pharmacological treatment both in adults as well as adolescents. Similarly, CBT significantly improves outcome in both age groups. This treatment consists of psychoeducation, exposure therapy, and cognitive restructuring. While both treatments produce clinically meaningful benefits, most patients exhibiting positive responses to these treatments continue to exhibit marked residual symptoms, if not full-blown anxiety disorders. Thus, there is great need for treatment advances.
Intense fear of social scrutiny represents a core component of social phobia, and extinction of this fear represents the goal of exposure therapy during CBT. Finding treatments that facilitate extinction is of paramount importance. In animals, extinction involves an active learning process that is blocked by glutamatergic NMDA antagonists and facilitated by NMDA agonists. Specifically, administration of D-cycloserine (DCS), a partial agonist at the glycine modulatory site on the NMDA receptor, produces a dose-dependent facilitation of extinction in the rat. As such, DCS might facilitate extinction during exposure-based CBT. Indeed, Ressler recently reported preliminary data from a clinical trial supporting this hypothesis.
We will examine the degree to which DCS treatment can augment the clinical response in social phobia to CBT-exposure-based therapy. Specifically, we will study two groups of individuals with social phobia, both of whom will receive CBT. One group will receive placebo; a second group will receive 50 mg of D-cycloserine 2 hours before each exposure therapy session. We hypothesize that compared to placebo, DCS will produce greater reductions in social anxiety symptoms during CBT treatment. Finally, given that chronic social anxiety disorder virtually always begins during childhood, it is particularly vital to develop early interventions for the disorder. Accordingly, our trial will examine both adolescents and adults with the disorder.
Eligibility
Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00128401
Maryland
National Institute of Mental Health (NIMH), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States; Recruiting
Patient Recruitment and Public Liaison Office 1-800-411-1222 prpl@mail.cc.nih.gov
TTY 1-866-411-1010
TTY 1-866-411-1010
More Information
Detailed Web Page
Publications
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.
Study ID Numbers: 050198; 05-M-0198
Last Updated: August 19, 2005
Record first received: August 8, 2005
ClinicalTrials.gov Identifier: NCT00128401
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 19, 2005
Record first received: August 8, 2005
ClinicalTrials.gov Identifier: NCT00128401
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23
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