Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia

NCT00128401 | Completed Phase 2 Results

• 2 other identifiers: 05019805-M-0198
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phobic Disorders; Anxiety; Social Phobia

Keywords

Cognitive; Behavioral; Adolescent; Therapy; Extinction; Social Phobia

Outcome Measures

Primary Outcomes (1)

• Clinical Global Improvement (CGI-S) Scale

  Symptom severity and improvement was assessed using the Clinical Global Impressions scale (CGI). It is a 2-item clinician-administered instrument that measures the patients' illness severity and global improvement. The minimum value for the CGI is 1=Normal, not at all ill and the maximum value is 7=Among the most extremely ill patients.

  12 weeks post baseline

Secondary Outcomes (1)

• Liebowitz Social Anxiety Scale (LSAS)

  12 weeks post baseline

Study Arms (2)

D-Cycloserine

ACTIVE COMPARATOR

An antibiotic, d-cycloserine (DCS) was given to one group and the group is evaluated to see if the drug boosts the effectiveness of cognitive behavior therapy (CBT) for social anxiety.

Drug: D-Cycloserine

Placebo

PLACEBO COMPARATOR

Another group was given the placebo and tested for effectiveness of cognitive behavior therapy (CBT) for social anxiety.

Drug: Placebo

Interventions

D-Cycloserine DRUG

D-Cycloserine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 8 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects between 8 yrs of age (preadolescents) and under 55 yrs of age.
• Subjects medically healthy.
• Able to give informed consent.
• Not on psychotropic meds for a minimum of 6 weeks for fluoxetine; a minimum of 1 week for PRN benzodiazepines and beta blockers, and a minimum of 3 weeks for all other psychotropic meds.
• Subjects diagnosed with DSM IV symptoms of social phobia, generalized or specific type.

You may not qualify if:

• Current major depressive disorder.
• Lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, mental retardation, substance or alcohol dependence (other than nicotine); active suicidal ideation.
• Current or lifetime history of a neurological disorder (other than tic disorders, febrile seizures of infancy), seizure disorder.
• Any unstable medical condition.
• Use of any psychoactive substance in the past 30 days.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1111/j.1600-0447.1984.tb01187.x.

  PMID: 6148843 BACKGROUND

• 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. doi: 10.1037//0022-006x.52.4.642. No abstract available.

  PMID: 6147366 BACKGROUND

• 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. doi: 10.1016/s0006-3223(99)00133-x.

  PMID: 10704956 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Phobic Disorders; Anxiety Disorders; Phobia, Social; Behavior

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The baseline mean and SD for CGI outcome measure was captured for 42 subjects only. The baseline mean and SD for LSAS outcome measure was captured for 40 subjects.

Results Point of Contact

• Title: Cameron, Jennifer Ann
• Organization: National Institute of Mental Health

cameronj@mail.nih.gov

+1 301 402 9356

Study Officials

• Jennifer A Cameron, C.R.N.P.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 9, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 20, 2014
• Results First Posted: May 20, 2014

Record last verified: 2014-04

Locations

US (1)