- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789813
Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders. (VALPRO)
October 1, 2018 updated by: Prof. Dominique de Quervain, MD
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, 4012
- Psychiatric University Clinics, University Basel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Valproic Acid and fear reactivation
This group will receive once a combination of 500mg Valproic Acid (oral solution) and fear reactivation before exposure therapy.
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Once oral administration of 500mg before exposure therapy.
Other Names:
Fear reactivation before exposure therapy.
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Active Comparator: Valproic Acid and no fear reactivation
This group will receive once 500mg Valproic Acid (oral solution) before exposure therapy.
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Once oral administration of 500mg before exposure therapy.
Other Names:
No fear reactivation before exposure therapy.
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Placebo Comparator: Placebo and fear reactivation
This group will receive once a combination of Placebo (oral solution) and fear reactivation before exposure therapy.
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Fear reactivation before exposure therapy.
Once oral administration of 500mg before exposure therapy.
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Placebo Comparator: Placebo and no fear reactivation
This group will receive once Placebo (oral solution) before exposure therapy.
|
No fear reactivation before exposure therapy.
Once oral administration of 500mg before exposure therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in performance in Behavioral Approach Test (BAT) in real-life (in vivo)
Time Frame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
|
Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in performance in BAT in virtual reality (in virtuo)
Time Frame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Change in subjective reactions in BAT in virtual reality (in virtuo)
Time Frame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Change in psychophysiological reactions in BAT in virtual reality (in virtuo)
Time Frame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Change in subjective reactions to fear-related picture cue presentation quantified by visual analog scales (VAS) for valence, arousal and fear
Time Frame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Change in psychophysiological reactions to fear-related picture cue presentation quantified by electrodermal activity (EDA), heart rate (HR), startle response
Time Frame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
|
Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
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Performance in working and recognition memory of pictures task
Time Frame: Follow up (visit 3: 90 days after visit 2: intervention)
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Follow up (visit 3: 90 days after visit 2: intervention)
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Valence, arousal, and mood ratings of pictures of working and recognition memory of pictures task
Time Frame: Follow up (visit 3: 90 days after visit 2: intervention)
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Follow up (visit 3: 90 days after visit 2: intervention)
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Change in strength of phobic fear quantified by self-report questionnaires
Time Frame: 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)
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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)
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Change in mood and state-anxiety quantified by self-report questionnaires
Time Frame: 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)
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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)
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Change in performance during exposure in virtuo quantified by eye tracking
Time Frame: Intervention (visit 2: 7-21 days after visit 1: baseline)
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Intervention (visit 2: 7-21 days after visit 1: baseline)
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Change in subjective reactions during exposure in virtuo quantified by subjective units of discomfort (SUD) ratings
Time Frame: Intervention (visit 2: 7-21 days after visit 1: baseline)
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Intervention (visit 2: 7-21 days after visit 1: baseline)
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Change in psychophysiological reactions during exposure in virtuo quantified by EDA and HR
Time Frame: Intervention (visit 2: 7-21 days after visit 1)
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Intervention (visit 2: 7-21 days after visit 1)
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Change in clinical relevance of phobic symptoms measured by Diagnostic Interview for Psychiatric Disorders (DIPS), section for specific phobia
Time Frame: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention)
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Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention)
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: 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)
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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)
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Blood pressure
Time Frame: 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)
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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)
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Heart rate
Time Frame: 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)
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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)
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VAS of headache, stomach pain, nausea, fatigue, dizziness, drowsiness muscle fatigue, and motivation.
Time Frame: 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)
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dominique JF de Quervain, MD, University of Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
April 20, 2016
First Submitted That Met QC Criteria
May 28, 2016
First Posted (Estimate)
June 3, 2016
Study Record Updates
Last Update Posted (Actual)
October 2, 2018
Last Update Submitted That Met QC Criteria
October 1, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016DR2001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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