Clinical trial NCT00590642: Augmentation in Tx-resistant OCD: an Open Label Trial
Official title: Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive Compulsive Disorder
Keywords: obsessive compulsive disorder
OCD
treatment-resistant
SSRI
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2008-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Psychiatry clinic

Brief summary: This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD.

Detailed description: A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor, on best medical judgment, may gradually increase or decrease the dose of the study medication. The adjustments will dependent on the subject's response and whether the subject has side effects. Once the subject has completed treatment under this study, the subject may resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.

Eligibility criteria: Inclusion Criteria:

* Men and women between 19-55 years of age
* have dx of OCD as determined by the structured clinical interview for DSM-IV axis 1 disorders
* SSRI resistant patients with OCD
* Subjects who are able to comprehend and satisfactorily comply with protocol requirements and have ability to read and write English.
* Signed written informed consent prior to entering any study procedures.
* Concomitant psychotropic medications permitted only if prescribed at stable dose for at least 1 month before screening visit

Exclusion Criteria:

* Patients with concurrent DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders
* Patients with concurrent DSM-IV diagnosis of mental retardation
* Patients with concurrent DSM-IV diagnosis of lifetime schizophrenia and other psychotic disorders
* Patients with concurrent DSM-IV diagnosis of lifetime bipolar disorder
* Substance dependence or abuse (excluding nicotine) within 6 months prior to screening visit
* Patients with score of less than 16 on Y-BCOS during screening.
* Patients with history of intolerance or hypersensitivity to acamprosate.
* Patients based on history or mental status exam have significant risk fo committing suicide.
* Patients who are homicidal or violent.
* Patients with severe renal impairment
* Female patients who are pregnant or lactating
* Subjects with history of psychosurgery for OCD

Primary outcomes:
measure: Acamprosate would be efficacious for SSRI resistant OCD symptoms
timeFrame: Patients will be administered 12 weeks of Acamprosate.
Secondary outcomes:
measure: Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD.
timeFrame: Patients will be administered 12 weeks of Acamprosate
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Department of Psychiatry
state: Nebraska
Study officials:
affiliation: Creighton University
name: Sriram Ramaswamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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