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A randomised, double-blind, placebo-controlled study on the impact of doxycycline on aversive memory in healthy individuals

Not Applicable
Recruiting
Conditions
healthy subjects
Registration Number
DRKS00017037
Lead Sponsor
Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
560
Inclusion Criteria

Informed Consent as documented by signature
- Age 18 – 40 years

Exclusion Criteria

• Allergy to doxycycline or to any other ingredient in the named drugs
• Use of any drugs in the 2 weeks prior to the study with the exception of contraceptive drugs and incidental use of NSARs or paracetamol
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Any history of psychiatric, neurological, addiction, or systemic/rheumatic disease
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems
• Participation in another study with investigational drug within 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Members of the study team and their family members and dependants
• Regular work in a medical profession
• Life time history of being a victim of interpersonal violence or other potentially traumatic experience, or close relative of a person with such history

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary endpoints are updated prompt to the start of a new experiment.<br>Experiment 1 and 2:<br>Fear-potentiated startle, measured via eyeblink EMG of the M. orbicularis oculi and quantified according to Khemka et al. (2017)<br>Detailed analysis plan: https://osf.io/6kj5u/.<br><br><br>Experiment 5:<br>Quantity and distress of intrusion in an intrusion diary during one week following the trauma film
Secondary Outcome Measures
NameTimeMethod
Experiment 1 und 2:<br>SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), pupil reaction, neuropsychological tests (e.g. VLM-T), questionnaires (STAI).<br><br>Experiment 5:<br>Questionnaires (e.g. STAI, BIS-BAS), SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), neuropsychological tests (e.g. VLM-T).
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