Augmentation in Tx-resistant OCD: an Open Label Trial | NCT00590642

Studies
Augmentation in Tx-resistant OCD: an Open Label Trial

NCT00590642

Sponsor

Creighton University

Status

Completed

Last Update Posted

Dec 1, 2009Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Obsessive Compulsive Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 28, 2007

First Posted Date

Jan 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2009

Last Update Posted Date

Dec 1, 2009Estimated

Name	Class
Forest Laboratories	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acamprosate would be efficacious for SSRI resistant OCD symptoms		Patients will be administered 12 weeks of Acamprosate.

Secondary Outcomes

Measure	Description	Time Frame
Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD.		Patients will be administered 12 weeks of Acamprosate

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Psychiatry clinic

Sampling Method

Probability Sample

Name	Affiliation	Role
Sriram Ramaswamy, MD	Creighton University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Creighton University Department of Psychiatry		Omaha	Nebraska	68131	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9166639	Background	Hollander E, Greenwald S, Neville D, Johnson J, Hornig CD, Weissman MM. Uncomplicated and comorbid obsessive-compulsive disorder in an epidemiologic sample. Depress Anxiety. 1996-1997;4(3):111-9. doi: 10.1002/(SICI)1520-6394(1996)4:33.0.CO;2-J.
3264144	Background	Karno M, Golding JM, Sorenson SB, Burnam MA. The epidemiology of obsessive-compulsive disorder in five US communities. Arch Gen Psychiatry. 1988 Dec;45(12):1094-9. doi: 10.1001/archpsyc.1988.01800360042006.

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders