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

A Randomized, Double-Blind, Placebo-Controlled Medication Trial With D-Cycloserine for Individuals With OCD Currently Receiving Behavior Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00182000

Enrollment

Registered

2005-09-16

Start date

2003-11-30

Completion date

Unknown

Last updated

2012-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Brief summary

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).

Detailed 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.

Interventions

DRUGseromycin

100mg tablet administered 1 hour prior to each therapy session

BEHAVIORALBehavior Therapy

10 weekly hour-long behavior therapy sessions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Yale-Brown Obsessive Compulsive Scale (YBOCS)	Post-treatment (week 5)	A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).

Secondary

Measure	Time frame
Obsessional Beliefs Questionnaire (OBQ)	Post-treatment (week 5)
Short-Form Health Survey (SF-36)	Post-treatment (week 5)
Beck Anxiety Inventory (BAI)	Post-treatment (week 5)
Clinical Global Impressions Scale (CGI)	Post-treatment (week 5)
Beck Depression Inventory (BDI)	Post-treatment (week 5)
Disability Inventory	Post-treatment (week 5)

Participant flow

Pre-assignment details

33 participants enrolled in the study. However, 4 participants decided not to participate in between consenting and starting treatment.

Participants by arm

Arm	Count
Seromycin 10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin	14
Placebo 10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo	15
Total	29

Baseline characteristics

Characteristic	Placebo	Seromycin	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	15 Participants	14 Participants	29 Participants
Age Continuous	38.07 years STANDARD_DEVIATION 12.28	38.29 years STANDARD_DEVIATION 13.01	38.18 years STANDARD_DEVIATION 12.4
Region of Enrollment United States	15 participants	14 participants	29 participants
Sex: Female, Male Female	6 Participants	6 Participants	12 Participants
Sex: Female, Male Male	9 Participants	8 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 14	0 / 15
serious Total, serious adverse events	0 / 14	0 / 15

Outcome results

Primary

Yale-Brown Obsessive Compulsive Scale (YBOCS)

A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).