Ketamine in OCD: Efficacy and Effects on Stress and Cognition

Sponsor
Medical University of Vienna
Study ID
NCT05577585
Status
Recruiting
Apply to this trial

Conditions

  • Obsessive-Compulsive Disorder
  • Psychiatric Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketamine 50 MG/ML Blinded — DRUG
    See also Arm description
  • Midazolam — DRUG
    See also Arm description
  • Ketamine 50 MG/ML Open Label — DRUG
    Open Label Follow Up (up to 8 Infusions)
  • Treatment as Usual (TAU) — OTHER
    Treatment as Usual may include psychotherapy, pharmacotherapy, physiotherapy, ergotherapy, or a combination of these-at the discretion of the treating physician, independently of the study.

Study Details

The main goal of this trial is to demonstrate therapeutic efficacy of low dose ketamine in patients with OCD. We expect that ketamine will alleviate symptoms in the hours following application, but also - if effective - that the anti-OCD effects might last for several days after a single infusion.

Key Dates

First listed
Oct 13, 2022
Start date
Oct 1, 2022
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ketamine
    Participants will undergo one infusion of ketamine as active comparator. (R,S-ketamine 50mg/ml solution for injection, dose: 0,5 mg per kg bodyweight) Both medications will be diluted in 100 ml saline and will be adjusted for infusion over 40 minutes, administered with a syringe pump.
  • Placebo Comparator: Midazolam
    Participants will undergo one infusion of midazolam as comparator. (0,045 mg/kg bodyweight) Both medications will be diluted in 100 ml saline and will be adjusted for infusion over 40 minutes, administered with a syringe pump.
  • Active Comparator: Treatment as Usual
    Participants will receive standard-of-care treatment-which may include psychotherapy, pharmacotherapy, physiotherapy, ergotherapy, or a combination of these-at the discretion of the treating physician, independently of the study.

Primary Outcome Measure

Change of OCD symptoms (Y-BOCS) [ Time Frame: In total 7 YBOCS assessments will take place between week 1 and 5. ]

Central Contacts

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