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Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy

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Mass General Brigham

Status and phase

Completed
Phase 3

Conditions

Obsessive-Compulsive Disorder

Treatments

Behavioral: Behavior Therapy
Drug: seromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT00182000
2003-P-001325

Details and patient eligibility

About

This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).

Full description

We hope to enroll 50 subjects in a double-blind, placebo-controlled study of D-cycloserine augmentation of behavior therapy for Obsessive-Compulsive Disorder. All subjects will undergo a pre-treatment assessment, and then be randomly assigned to receive Seromycin (100 mg) or placebo one-hour before each of 10 therapy sessions. Subjects will then come in for a treatment planning session and the behavior therapy sessions delivered twice weekly for 5 weeks. Comprehensive assessments of obsessive-compulsive symptoms, mood state, and cognitions will be given at baseline, after 5 treatment sessions, after 10 sessions and 1 month and 6 months post-treatment.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Structured Clinical Interview for DSM-IV (SCID) diagnosis of Obsessive Compulsive Disorder
  • Score of greater than 16 on the Yale-Brown Obsessive Compulsive Scale
  • Negative urinary beta-Human Chorionic Gonadotropin (hCG) test

Exclusion criteria

  • Currently taking or have taken an unstable dose of psychotropic medications within 2 months prior to enrollment
  • Currently taking medications that may interfere with the study medication
  • History of seizure disorder or other serious medical illnesses (e.g., cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or blood-related disease)
  • Current diagnosis of tuberculosis
  • Other psychiatric diagnoses (e.g., alcohol dependence, bipolar disorder, psychosis, organic mental disorder, or development disorder) that are of greater concern than the obsessive-compulsive disorder diagnosis
  • Currently taking medications that may lower seizure threshold (e.g., including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem)
  • Poses a serious suicidal or homicidal threat
  • Currently undergoing psychotherapy
  • Failure to benefit from ten or more sessions of previous Exposure and Response Prevention (ERP) treatment
  • Pregnant or breastfeeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

33 participants in 2 patient groups, including a placebo group

Seromycin
Active Comparator group
Treatment:
Drug: seromycin
Behavioral: Behavior Therapy
Placebo
Placebo Comparator group
Treatment:
Behavioral: Behavior Therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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