CClinicalTrials.gg
Sign In
CompletedNCT02789813VALPROUpdated Oct 2, 2018

Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders.

A Phase 2 interventional study of Valproic Acid and Placebo in Phobia, Specific, sponsored by Prof. Dominique de Quervain, MD. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Prof. Dominique de Quervain, MD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Phobia, Specific
03

In context

Lead sponsor

Prof. Dominique de Quervain, MD is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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.

    Drug: Valproic Acid · Behavioral: Fear reactivation

  • Active comparator
    Valproic Acid and no fear reactivation

    This group will receive once 500mg Valproic Acid (oral solution) before exposure therapy.

    Drug: Valproic Acid · Behavioral: No fear reactivation

  • Placebo comparator
    Placebo and fear reactivation

    This group will receive once a combination of Placebo (oral solution) and fear reactivation before exposure therapy.

    Drug: Placebo · Behavioral: Fear reactivation

  • Placebo comparator
    Placebo and no fear reactivation

    This group will receive once Placebo (oral solution) before exposure therapy.

    Drug: Placebo · Behavioral: No fear reactivation

Interventions

  • DrugValproic Acid

    Once oral administration of 500mg before exposure therapy.

    Also known as: Orfiril®

  • DrugPlacebo

    Once oral administration of 500mg before exposure therapy.

  • BehavioralFear reactivation

    Fear reactivation before exposure therapy.

  • BehavioralNo fear reactivation

    No fear reactivation before exposure therapy.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Performance in working and recognition memory of pictures task

    Time frame: Follow up (visit 3: 90 days after visit 2: intervention)

  7. 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)

  8. 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)

  9. 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)

  10. Change in performance during exposure in virtuo quantified by eye tracking

    Time frame: Intervention (visit 2: 7-21 days after visit 1: baseline)

  11. 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)

  12. Change in psychophysiological reactions during exposure in virtuo quantified by EDA and HR

    Time frame: Intervention (visit 2: 7-21 days after visit 1)

  13. 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)

Other outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

07

Study locations

1 site
  • Psychiatric University Clinics, University Basel
    Basel, 4012, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02789813
Lead sponsor
Prof. Dominique de Quervain, MD
Responsible party
Prof. Dominique de Quervain, MD (MD, University of Basel) — Sponsor-investigator
First posted
Jun 3, 2016
Start date
Jul 2016
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Oct 2, 2018

Study contacts

Dominique JF de Quervain, MD
principal investigator · University of Basel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Prof. Dominique de Quervain, MD

Start the discussion