Deep brain stimulation for severe obsessive-compulsive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of deep brain stimulation (DBS) in patients with severe and treatment-resistant obsessive-compulsive disorder (OCD). Participants will be randomly assigned to receive either active or sham DBS targeting the bed nucleus of stria terminalis (BNST) for six months. The primary outcome is the reduction of OCD symptoms, while secondary outcomes include changes in anxiety, depressive symptoms, and daily functioning. Following the initial phase, all participants will receive continuous DBS and will be monitored with yearly follow-ups using validated psychometric scales.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
* Severe OCD symptoms: YBOCS ≥ 25 points.
* Substantial incapacity because of his/her symptoms.
* Duration of symptoms: 5 years minimum.
* Understand the consequences of participation in the study and give informed written consent.

Exclusion Criteria:

* Not being able to understand the consequences of the treatment.
* Diagnosed with intellectual disability according to DSM-IV.
* Not meeting the requirements for the neurosurgery procedure.

Where it's running

• Umeå University
  Umeå, Västerbotten County, Sweden Recruiting

Study contacts

• Study coordinator: Viktoria Johansson, PhD
• Email: viktoria.johansson@umu.se
• Phone: +46-90-786 50 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.