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OpenTrials
Completed

NCT Number: NCT00590642

Augmentation in Tx-resistant OCD: an Open Label Trial

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.

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Creighton University Department of Psychiatry

Omaha, Nebraska, 68131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Acamprosate would be efficacious for SSRI resistant OCD symptoms

    Time frame: Patients will be administered 12 weeks of Acamprosate.

Secondary outcomes

  1. Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD.

    Time frame: Patients will be administered 12 weeks of Acamprosate

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 10, 2008
Registry last updated
Dec 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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