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

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

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;
• Pregnant or breast feeding female patients;
• Previous use of MDMA or ecstacy;
• Blood donation according to the limits of the blood donation service prior to the first challenge.
• Participation in an investigational drug study within 90 days prior to the first challenge, or participation in four studies (or more) in the year prior to the first challenge.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints<br /><br>• Plasma ACTH<br /><br>• Serum total and free cortisol<br /><br>• Serum prolactin<br /><br>• Saliva free cortisol<br /><br>• Bond and Lader Visual Analogue Scale (VAS) for alertness, mood, calmness and<br /><br>nausea.<br /><br>• Adverse Event reporting (AE*s).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>Pharmacokinetics:<br /><br>• plasma 5-HTP concentrations.<br /><br><br /><br>Psychometric parameters:<br /><br>• Brief Symptom Inventory (BSI);<br /><br>• Comprehensive Psychopathological Rating Scale (CPRS)<br /><br><br /><br>Safety:<br /><br>• Blood pressure, Heart Rate, Body temperature, electrocardiogram</p><br>