NL-OMON33643
Withdrawn
Not Applicable
A randomized, parallel, double-blind, placebo controlled trial to investigate HPA-axis activation before and after electro-convulsive therapy in patients with a major depressive episode using an orally administered 5-HTP challenge test - 5-HTP challenge in patients with a major depressive episode.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- depression
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 30
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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 \< 19;
- •Use of prescribed drugs with a known effect on the serotonergic system. A minimum of 7 days medication\-free days prior to the first challenge will be maintained except for drugs requiring a longer washout period due to kinetic properties. Specifically the use of serotonergic antidepressant drugs (SSRI\*s, SNRI\*s, TCA\*s, MAOI\*s, Lithium and atypical antipsychotic) are prohibited for the mentioned periods;
- •Use of prescribed drugs with a known effect on the HPA\-axis within 2 weeks of the first challenge. Specifically current oral corticosteroid use is prohibited.
- •Comorbid post\-traumatic stress disorder (PTSD);
- •Clinically significant neuroendocrine disorders, specifically previous or current diagnosis of Cushing\*s disease, Addison\*s disease or adrenalectomy;
- •Any other clinically significant concomitant disease which may negatively influence the study objectives or affect the patients\* compliance to study procedures;
- •Known history of adverse reactions to 5\-HTP, carbidopa or granisetron.
- •Use of illicit drugs within two weeks prior to the first challenge;
Outcomes
Primary Outcomes
Not specified
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