Clinical trial NCT02789813: Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders.
Official title: Randomized Placebo-controlled Phase II Study on the Influence of Valproic Acid in Combination With Reactivation of Fear Memory on the Outcome of Extinction-based Therapy in Patients With Fear of Spiders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Phobia, Specific
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: * There will be one screening visit (visit 1), one intervention visit (visit 2) and one follow-up visit (90 days after visit 2) (visit 3).
* On visit 2 all participants will undergo 30 min exposure therapy in virtual reality with pre-defined spider situations.
* Duration for an individual participant will be at most 15 weeks depending on the time passing between screening (visit 1) and intervention visit (visit 2).
* Change in phobic fear to baseline (visit 1) will be assessed on 90 day follow-up (visit 3).
* Documentation of all study relevant source data of every study participant will be done by completing the study specific electronic case report forms (eCRF, SoSci Survey) and study specific case report forms on paper (Adverse Events, Serious Adverse Events and concomitant medication). Data in the eCRF can be validated for completeness and discrepancies automatically. An audit trail system maintains a record of initial entries and changes (reasons for changes, time and date of changes, user identification of entry and changes).
* Quality insurance will be done by an external site monitoring (including study progress, accuracy and completeness of eCRF, fulfillment of protocol requirements, applicable local authority regulations and investigator's obligations).
* Monitoring includes 100% of safety parameters, primary endpoints, informed consent documents and the Trial Master File on the Initiation Visit and on Close Out.
* Standard Operating Procedures to address study activities such as patient recruitment, informed consent, study interventions, data collection, data management, data analysis, and reporting for adverse events exist.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Change in performance in BAT in virtual reality (in virtuo)
timeFrame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
measure: Change in subjective reactions in BAT in virtual reality (in virtuo)
timeFrame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
measure: Change in psychophysiological reactions in BAT in virtual reality (in virtuo)
timeFrame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
measure: Change in subjective reactions to fear-related picture cue presentation quantified by visual analog scales (VAS) for valence, arousal and fear
timeFrame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
measure: Change in psychophysiological reactions to fear-related picture cue presentation quantified by electrodermal activity (EDA), heart rate (HR), startle response
timeFrame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
measure: Performance in working and recognition memory of pictures task
timeFrame: Follow up (visit 3: 90 days after visit 2: intervention)
measure: Valence, arousal, and mood ratings of pictures of working and recognition memory of pictures task
timeFrame: Follow up (visit 3: 90 days after visit 2: intervention)
measure: Change in strength of phobic fear quantified by self-report questionnaires
timeFrame: Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention)
measure: Change in mood and state-anxiety quantified by self-report questionnaires
timeFrame: Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention)
measure: Change in performance during exposure in virtuo quantified by eye tracking
timeFrame: Intervention (visit 2: 7-21 days after visit 1: baseline)
measure: Change in subjective reactions during exposure in virtuo quantified by subjective units of discomfort (SUD) ratings
timeFrame: Intervention (visit 2: 7-21 days after visit 1: baseline)
measure: Change in psychophysiological reactions during exposure in virtuo quantified by EDA and HR
timeFrame: Intervention (visit 2: 7-21 days after visit 1)
measure: Change in clinical relevance of phobic symptoms measured by Diagnostic Interview for Psychiatric Disorders (DIPS), section for specific phobia
timeFrame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention)
Other outcomes:
measure: Adverse Events
timeFrame: Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention)
measure: Blood pressure
timeFrame: Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention)
measure: Heart rate
timeFrame: Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention)
measure: VAS of headache, stomach pain, nausea, fatigue, dizziness, drowsiness muscle fatigue, and motivation.
timeFrame: Baseline (7-21 days before visit 2: intervention), intervention (visit 2: 7-21 days after visit 1: baseline) and follow up (visit 3: 90 days after visit 2: intervention)
Locations:
city: Basel
country: Switzerland
facility: Psychiatric University Clinics, University Basel
Study officials:
affiliation: University of Basel
name: Dominique JF de Quervain, MD
role: PRINCIPAL_INVESTIGATOR
References: