Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders. (NCT02789813) | Clinical Trial Compass
CompletedPhase 2
Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders.
Switzerland100 participantsStarted 2016-07
Plain-language summary
The purpose of this study is to evaluate whether valproic acid in combination with fear memory reactivation is useful to enhance treatment stability of exposure therapy for specific phobia.
Who can participate
Age range18 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* DSM-IV diagnosis of specific phobia (animal type: spider)
* BAT score (at screening) between 1 and 7 points
* Physically healthy
* Normotensive (90/60-140/90 mmHg)
* Male or female
* Aged between 18 and 40 years
* Native or fluent German-speaking
* Females have to be on effective birth control
Exclusion Criteria:
* Other axis I disorder except a further comorbid phobic disorder
* Concurrent psychotherapy or pharmacotherapy
* Previous exposure-based therapy for specific phobia
* Parallel participation in another study
* Body weight less than 50kg
* Long-term medication intake
* Substance abuse
* 5 or more cigarettes a day and/or inability of being abstinent for at least 5 hours
* Pregnancy or breast-feeding
* Kinetosis
* History of coagulation disease
* History of gastrointestinal disease
* Laboratory exclusion criteria: clinically relevant deviation of laboratory values (blood count, blood chemistry, coagulation status, liver and pancreas enzymes, electrolytes) from normal range
What they're measuring
1
Change in performance in Behavioral Approach Test (BAT) in real-life (in vivo)
Timeframe: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention