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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00010230 |
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Date of registration:
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01/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomised, double-blind, placebo-controlled, multi-arm study on the impact of Valproic acid and Pregabalin on approach/avoidance behaviour in healthy individuals
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Scientific title:
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A randomised, double-blind, placebo-controlled, multi-arm study on the impact of Valproic acid and Pregabalin on approach/avoidance behaviour in healthy individuals - AAAX2 |
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Date of first enrolment:
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08/06/2016 |
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Target sample size:
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90 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00010230 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: basic science
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Dominik
Bach |
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Address:
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Lenggstrasse 31, Postfach 1931
8032
Zürich
Switzerland |
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Telephone:
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+41443842111 |
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Email:
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dominik.bach@uzh.ch |
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Affiliation:
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Psychiatrische Universitätsklinik Zürich |
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Name:
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Dominik
Bach |
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Address:
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Lenggstrasse 31, Postfach 1931
8032
Zürich
Switzerland |
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Telephone:
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+41443842111 |
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Email:
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dominik.bach@uzh.ch |
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Affiliation:
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Psychiatrische Universitätsklinik Zürich |
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Key inclusion & exclusion criteria
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Inclusion criteria: Healthy individuals between 18-40 years
Exclusion criteria: • Allergy to Valproic acid or Pregabalin 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, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
• Acute or chronic hepatitis, hepatic porphyria
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Any history of psychiatric, neurological, dependence 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 the 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
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Investigate and compare the impact of Valproic acid and Pregabalin on healthy human volunteers 'anxiety-like' behaviour in a computer game.
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Intervention(s)
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Group 1: Single dose 400 mg Valproic acid (2-Propylpentanoic acid), oral capsules for 1 day
Group 2: Single dose 200 mg Pregabalin ((S)-3-(aminomethyl)-5-methylhexanoic acid), brand name Lyrica, oral capsules for 1 day
Group 3: Single dose placebo (mannitol), oral capsules for one day
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Primary Outcome(s)
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Primary outcome is the overall probability of being in the safe place in the computer game. Probability of being in the safe place will be assessed over all rounds of the experiment and analysed in a time x task x threat level factorial design. Probability of being in the safe place is a surrogate marker for passive avoidance, and was highly sensitive in distinguishing between patients with hippocampal or amygdala lesions and healthy controls, and between lorazepam and placebo, in a previous study.
Measured during the entire computer game (average behaviour in the computer game).
[NOTE: this is the primary outcome as per approved study protocol. An earlier version of the registration did not match the study protocol due to an administrative oversight, and this was corrected before study completion/drug unblinding.]
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Secondary Outcome(s)
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Secondary outcomes are distance from threat, distance from walls, probability of being in the threat quadrant, probability of being in the safe quadrant, rate of token collection and speed when on grid, in the computer game. All secondary outcomes will be assessed over all rounds of the experiment and analyzed in a time x task x threat level factorial design.
Measured during the entire computer game (average behaviour in the computer game).
[NOTE: these are the secondary outcomes as per approved study protocol. An earlier version of the registration did not match the study protocol due to an administrative oversight, and this was corrected before study completion/drug unblinding.]
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Source(s) of Monetary Support
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University of Zurich
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Ethics review
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Status: Approved
Approval date: 06/03/2015
Contact:
Kantonale Ethikkommission Zürich [Zürich Cantonal Ethics Committee (Kantonale Ethikkommission Zürich)]
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