depression depressive disorder
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female sex • Age of 18-75 years (extremes included); • Diagnosed with a major depressive episode according to DSM-IV by attending psychiatrist; • Scheduled for an ECT course; • Signed Informed Consent;
Exclusion criteria
Exclusion criteria: • Severe hallucinations, delusions,or disorganized behaviour that could interfere with study compliance and/or provision of informed consent as to judgment of the psychiatrist; • Suicidal intent or behaviour that may render participation dangerous to the patient and/or to the staff as to judgment of the psychiatrist; • Severe cognitive impairment could interfere with study compliance and/or provision informed consent as to judgment of the psychiatrist or a MMSE score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoints • Plasma ACTH • Serum total and free cortisol • Serum prolactin • Saliva free cortisol • Bond and Lader Visual Analogue Scale (VAS) for alertness, mood, calmness and nausea. • Adverse Event reporting (AE*s). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Pharmacokinetics: • plasma 5-HTP concentrations. Psychometric parameters: • Brief Symptom Inventory (BSI); • Comprehensive Psychopathological Rating Scale (CPRS) Safety: • Blood pressure, Heart Rate, Body temperature, electrocardiogram | — |
Countries
Netherlands
Outcome results
None listed