Obsessive-compulsive disorder
Conditions
Interventions
Trade Name: Ketamin-hameln 50mg/ml Injektionslösung
Product Name: Ketamin-hameln 50 mg/ml Injektionslösung
Pharmaceutical Form: Injection/infusion
INN or Proposed INN: KETAMINE
CAS Number: 6740-88-1
C
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary diagnosis of obsessive-compulsive disorder A score of 16 or higher on the Yale-Brown Obsessive Compulsive Scale Age of at least 18 years and ability to provide written informed consent One previous treatment for OCD Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 Current unstable suicidality Morbus Raynaud Unstable hypertension Any other severe and unstable cardiovascular disease Untreated hyperthyroidism Untreated disorders severely affecting the HPA-axis (M.Addison, M.Cushing) Current pharmacological therapy severely affecting the HPA-axis like corticosteroids or ACTH Inability to follow the study protocol or adhere to operational requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the prolonged efficacy of ketamine in alleviating symptoms of patients with OCD (7 days);Secondary Objective: To investigate the prolonged efficacy of ketamine in alleviating symptoms of patients with OCD (24 hours) To investigate the prolonged efficacy of ketamine in alleviating symptoms of patients over the course of 7 days. (VAS) To investigate the effects of ketamine on neuropsychological function under stress in patients with OCD. To investigate the effects of ketamine on hormonal stress response measured by salivary cortisol levels in patients with OCD. To investigate the effects of ketamine on vegetative stress response measured by blood pressure and heart rate in patients with OCD.;Primary end point(s): Significant reduction of symptoms measured by Yale-Brown Obsessive-Compulsive Scale after application of intravenous ketamine ;Timepoint(s) of evaluation of this end point: 1 and 7 days after each infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Treatment success for the individual patient, defined as 35% reduction in Y-BOCS scores from baseline. Symptom alleviation measured by YBOCS and OCD visual analogue scale score will persist for up to seven days Significant reduction of obsessive thoughts after ketamine infusion, measured by OCD visual analogue scale in comparison to placebo Effects of ketamine infusion on neuropsychological functions under stress measured by WCST, SSRT, N-back and ToH Effects of ketamine infusion on hormonal stress response measured by salivary cortisol levels Effects of ketamine infusion on vegetative stress response measured by blood pressure and heart rate Effects of ketamine infusion on subjective stress levels after acute stress induction measured by a visual analogue scale.;Timepoint(s) of evaluation of this end point: -YBOCS Score: baseline, one and seven days after each infusion -subjective obsessions: before, during, immediately after infusion and once every day post infusion for seven days -neurocognitive tests, subjective stress, hormonal and vegetative stress response: 3 time points, 1 baseline, 1 after each infusion | — |
Countries
Austria
Contacts
Public ContactChristoph Kraus
Departement of Psychiatry and Psychotherapy, Medical University of Vienna
Outcome results
None listed