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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00017037
• Date of registration: 05/11/2019
• Prospective Registration: No
• Primary sponsor: Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich
• Public title: A randomised, double-blind, placebo-controlled study on the impact of doxycycline on aversive memory in healthy individuals
• Scientific title: A randomised, double-blind, placebo-controlled study on the impact of doxycycline on aversive memory in healthy individuals - DoxAv
• Date of first enrolment: 29/10/2019
• Target sample size: 560
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00017037
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: basic science
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Birgit Kleim
• Affiliation: Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich

• Name: Jelena Wehrli
• Affiliation: Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

healthy subjects

Intervention(s)

Group 1: Vibramycin® Tabs (Doxycyline), 200mg capsule, oral administration, single-dose.

6 experiments will examine whether aversive memories of healthy participants can be influenced by the antibiotic doxycycline. The experiments will be conducted over the time span of several days, however, the medicament will only be taken once, either at the time of memory consolidation or reconsolidation.


Group 2: Placebo Mannitol PhEur (Perlitol 200SD)
200mg capsule, oral administration, single-dose

Primary Outcome(s)

Primary endpoints are updated prompt to the start of a new experiment.
Experiment 1 and 2:
Fear-potentiated startle, measured via eyeblink EMG of the M. orbicularis oculi and quantified according to Khemka et al. (2017)
Detailed analysis plan: https://osf.io/6kj5u/.


Experiment 5:
Quantity and distress of intrusion in an intrusion diary during one week following the trauma film

Secondary Outcome(s)

Experiment 1 und 2:
SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), pupil reaction, neuropsychological tests (e.g. VLM-T), questionnaires (STAI).

Experiment 5:
Questionnaires (e.g. STAI, BIS-BAS), SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), neuropsychological tests (e.g. VLM-T).

Secondary ID(s)

SNCTP000003485

Source(s) of Monetary Support

Universität Zürich

Ethics review

Status: Approved
Approval date: 14/05/2019
Contact:

Kantonale Ethikkommission Zürich [Kantonale Ethikkommission Zürich KEK-ZH]

Results

• URL: http://drks.de/search/en/trial/DRKS00017037#studyResults