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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000280

Enrollment

Registered

2010-01-04

Start date

2010-04-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32 F33

Interventions

Group 1: Placebo, capsules, oral, day 1-35, once daily in the morning Group 2: Fluoxetin hydrochloride, capsules, oral, once daily in the morning Titration phase: day 1+2: 10 mg/d

day 3+4: 20 mg/d, Treating phase: day 5-28: 30 mg/d Reduction phase: day 29-32: 20 mg/d

Tag 33-35 10 mg/d Group 3: Paroxetin hydrochloride, capsules, oral, once daily in the morning Titration phase: day 1: 10 mg/d

day 2-4: 20 mg/d, Treating phase: day 5-28: 40 mg/d Reduction phase: day 29-31: 20 mg/d

day 32-35: 10 mg/d

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
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°). serum levels of fluoxetine and paroxetine, respectively. clinically relevant changes noticed in the physical examination, ECG recording or assessment of routine lab. incidences of adverse events (AEs) reported by the participant, either spontaneously or by filling in a study-specific AE checklist. Parameters will be determined prior to (day1), during therapy (day 3,7,14,21,28) and 1 week after cessation of the study medication	—

Measure

Time frame

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°). serum levels of fluoxetine and paroxetine, respectively. clinically relevant changes noticed in the physical examination, ECG recording or assessment of routine lab. incidences of adverse events (AEs) reported by the participant, either spontaneously or by filling in a study-specific AE checklist. Parameters will be determined prior to (day1), during therapy (day 3,7,14,21,28) and 1 week after cessation of the study medication

—

Primary

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactAndrea Rotter-Neubert

Universitätsklinikum Erlangen Psychiatrische und Psychotherapeutische Klinik

andrea.rotter@uk-erlangen.de09131/ 85-44888

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026