Impact of selective serotonine re-uptake-inhibitors on acid sphingomyelinase activity in peripheral leucocytes of healthy adult male volunteers

Phase 1

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00000280
• Lead Sponsor: niversitätsklinikum Erlangen Psychiatrische und Psychotherapeutische Klinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-04
• Study Completion: 2010-09-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Healthy
Able to understand the risks involved in their participation in the trial
Able to understand and follow explanations and instructions of the Investigator and other study personnel
Ability to take part in the weekly visits
Given informed consent

Exclusion Criteria

Known allergy to any of the study drugs
Significant psychiatric or neurological disorder
Addiction to drugs or alcohol (except to coffeine or nicotine)
Inmate at a psychiatric hospital
Significant cardiovascular, gastrointestinal, hepatic or renal disorder
Significant abnormalities in the ECG, specifically QTc prolongation >440 msec
Values outside the normal range in routine lab assessments
Participation in another clinical trial in the preceding 3 months
Administration of any psychotropic medication in the preceding 30 days

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASM activity in peripheral leucocytes. ASM-activity will be determined in peripheral leucocytes prior to (day1), during therapy (day 3,7,14,21,28), and 1 week after cessation (day 35) of the study medication. ASM-activity will be measured in leucocytes of the respective proband taken at the given timepoints using an in vitro-Assay.

Secondary Outcome Measures

Name	Time	Method
neuropsychological changes under treatment with study medication assessed by administration of a battery of validated psychometric tests (SKT, D2, MSS, BDI , SCL-90R, BL', BL°).<br><br>serum levels of fluoxetine and paroxetine, respectively.<br>clinically relevant changes noticed in the physical examination, ECG recording or assessment of routine lab.<br>incidences of adverse events (AEs) reported by the participant, either spontaneously or by filling in a study-specific AE checklist.<br>Parameters will be determined prior to (day1), during therapy (day 3,7,14,21,28) and 1 week after cessation of the study medication