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NCT Number: NCT06628752

Deep Brain Stimulation for Obsessive-compulsive Disorder

The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).

The main research questions are:

* Does active DBS in BNST reduce OCD symptoms (primary outcome)? * Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function?

The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Deep brain stimulation

Device

Stimulation through a device implanted bilaterally into deep brain structures.

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale, Y-BOCS

    Time frame: From enrollment to the end of treatment after 6 months.

    Validated psychometric scale that measures symptoms of OCD.

Secondary outcomes

  1. Hamilton Anxiety Scale, HAS

    Time frame: From enrollment to the end of treatment after 6 months.

    Validated psychometric scale that measures symptoms of anxiety.

  2. Hamilton Depression scale, HAMD

    Time frame: From enrollment to the end of treatment after 6 months.

    Validated psychometric scale that measures symptoms of depression.

  3. Montgomery Asberg Depression Rating Scale, MADRS

    Time frame: From enrollment to the end of treatment after 6 months.

    Validated psychometric scale that measures symptoms of depression.

  4. Global Assessment of Functioning, GAF

    Time frame: From enrollment to the end of treatment after 6 months.

    Scale that measures level of functioning.

  5. Clinical Global Impression rating scale, CGI

    Time frame: From enrollment to the end of treatment after 6 months.

    Scale that measures symptom improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Matilda Naesstrom, PhD

CONTACT

[email protected]

+46-90-786 50 00

Viktoria Johansson, PhD

CONTACT

[email protected]

+46-90-786 50 00

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Västerbotten

Registry information

Official study title

Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Oct 8, 2024
Registry last updated
Oct 17, 2024

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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