Studying the impact of Doxycycline on fear memory in healthy individuals

• Register: ISRCTN
• Last refreshed on: 25 July 2023
• Main ID: ISRCTN66987216
• Date of registration: 23/06/2015
• Prospective Registration: Yes
• Primary sponsor: Psychiatric University Hospital (Psychiatrische Universitätsklinik) Zürich (PUK ZH)
• Public title: Studying the impact of Doxycycline on fear memory in healthy individuals
• Scientific title: A randomised, double-blind, placebo-controlled, two-phase study on the impact of Doxycycline on fear memory in healthy individuals
• Date of first enrolment: 01/11/2015
• Target sample size: 160
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN66987216
• Study type: Interventional
• Study design: Randomised placebo-controlled double-blind trial (Other)
• Phase: Not Applicable

Countries of recruitment

Switzerland

Contacts

• Name: Dominik Bach

Key inclusion & exclusion criteria

Inclusion criteria: 1. Informed consent as documented by signature
2. Age 18 – 40 years
Exclusion criteria: 1. Allergy to Doxycycline or to any other ingredient in the named drug
2. 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
3. Women who are pregnant or breast feeding
4. Intention to become pregnant during the course of the study
5. 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, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, combined with a mechanical contraceptive (condom, diaphragm)
6. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
7. Any history of psychiatric, neurological, dependence or systemic/rheumatic disease
8. Known or suspected non-compliance, drug or alcohol abuse
9. Inability to follow the procedures of the study, e.g. due to language problems
10. Participation in another study with investigational drug within the 30 days preceding and during the present study
11. Previous enrolment into the current study
12. Members of the study team and their family members and dependants

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Fear memory
Not Applicable

Intervention(s)

A single dose 200 mg of Doxycycline or placebo

Primary Outcome(s)

Current primary outcome measures as of 25/08/2016:
The difference in fear memory recall between a fear-conditioned CS+ and a safety-conditioned CS-, as estimated from startle eye blink EMG (The initially registered primary outcome, skin conductance responses, is not measured during the memory recall phase, due to a change in study design before inclusion of the first participant)

Previous primary outcome measures:
The difference in fear memory between a fear-conditioned CS+ and a safety-conditioned CS-, as estimated from skin conductance responses.

Secondary Outcome(s)

Current secondary outcome measures as of 25/08/2016:
Fear memory indices derived from skin conductance responses and heart rate during fear acquisition and re-learning

Previous secondary outcome measures:
A fear memory index derived from heart rate, pupil size, and startle response quantified via EMG of the M. orbicularis oculi

Secondary ID(s)

DoxMem

Source(s) of Monetary Support

Universität Zürich

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Kantonale Ethikkommission Zürich, 23/04/2015, ref: KEK-ZH-Nr.2014-0669

Results

• Results available: Yes
• Date Completed: 27/07/2018