Clinical TrialObsessive-Compulsive Disorder (OCD)KetamineKetaminePlaceboRecruiting

Ketamine and Stress in OCD

Randomized, double-blind, comparator-controlled crossover trial (n=30) testing low-dose IV ketamine (0.5 mg/kg, 40 min infusion) versus midazolam in patients with OCD at the Medical University of Vienna.

Target Enrollment
30 participants
Study Type
Phase NA interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, double-blind, triple-masked crossover study comparing a single IV ketamine infusion (0.5 mg/kg over 40 minutes) with midazolam in adults with primary OCD; sequences separated by a 14-day washout and stratified by baseline YBOCS severity.

Outcomes include acute and short-term anti-OCD effects, neurocognitive performance on four tasks, stress responsivity using a cold pressor test, and EEG measures during and after infusions.

An optional open-label continuation offers up to eight ketamine infusions over a month compared with treatment-as-usual; additional EEG assessment follows completion of open-label treatment.

Study Protocol

Preparation

sessions

Dosing

2 sessions
40 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

Single IV infusion of ketamine (0.5 mg/kg) in crossover; optional open-label continuation (up to 8 infusions).

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Diluted in 100 ml saline; infused over 40 minutes.

  • Ketamine0.5 mg/kg
    via IV• up to 8 infusions over 1 month• 8 doses total

    Open-label continuation phase (optional).

Midazolam

inactive

Comparator infusion of midazolam (0.045 mg/kg) administered IV over 40 minutes.

Interventions

  • Placebo0.045 mg/kg
    via IV• single dose• 1 doses total

    Midazolam comparator; diluted in 100 ml saline; infused over 40 minutes.

Treatment as Usual

active comparator

Standard-of-care treatment at physician discretion (psychotherapy, pharmacotherapy, physiotherapy, ergotherapy or combination).

Interventions

  • Compound
    via Other• variable

    Treatment as usual (TAU) comparator for open-label phase.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Primary diagnosis of obsessive-compulsive disorder
  • A score of 16 or higher on the Yale-Brown Obsessive Compulsive Scale and ability to provide written informed consent
  • At least one previous treatment for OCD

Exclusion Criteria

  • Exclusion Criteria Experimental Group:
  • Any history of current or past psychotic disorder
  • A manic episode within the preceding three years
  • Current or unstable remitted substance abuse or dependence except nicotine
  • Pregnancy or elevated risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception
  • Any current severe personality disorder except comorbid anankastic personality disorder
  • Morbus Raynaud
  • Inability to follow the study protocol or adhere to operational requirements
  • Current and unstable suicidality
  • Unstable hypertension
  • Untreated hyperthyroidism
  • Any unstable cardiovascular disease
  • Untreated disorders severely affecting the HPA-axis (M.Addison, M.Cushing)
  • Current pharmacological therapy severely affecting the HPA-axis like corticosteroids or ACTH
  • Exclusion Criteria Treatment as Usual Group:
  • Any history of current or past psychotic disorder
  • A manic episode within the preceding three years
  • Current or unstable remitted substance abuse or dependence except nicotine
  • Any current severe personality disorder except comorbid anankastic personality disorder
  • Current and unstable suicidality

Study Details

Locations

Medical University of Vienna, Department of Psychiatry and Psychotherapy — Vienna, Vienna, Austria

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