Phobia, SpecificPhase 2VALPRONCT02789813
Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders.
A Phase 2 study testing Valproic Acid, Fear reactivation and No fear reactivation in people with Phobia, Specific, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Phobia, Specific
- What is being tested?
- Valproic Acid, Fear reactivation and No fear reactivation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to 30 Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric University Clinics, University Basel
Basel, 4012
About this study
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.
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.
- Conditions
- Phobia, Specific
- Being tested
- Valproic Acid, Placebo, Fear reactivation, No fear reactivation
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic AcidDrug
Also called Orfiril®
Once oral administration of 500mg before exposure therapy.
PlaceboDrug
Once oral administration of 500mg before exposure therapy.
Fear reactivationBehavioural
Fear reactivation before exposure therapy.
No fear reactivationBehavioural
No fear reactivation before exposure therapy.
| Study group | Role | What they receive |
|---|---|---|
| Valproic Acid and fear reactivation | Experimental | This group will receive once a combination of 500mg Valproic Acid (oral solution) and fear reactivation before exposure therapy. Receives: Drug: Valproic Acid; Behavioral: Fear reactivation |
| Valproic Acid and no fear reactivation | Active comparator | This group will receive once 500mg Valproic Acid (oral solution) before exposure therapy. Receives: Drug: Valproic Acid; Behavioral: No fear reactivation |
| Placebo and fear reactivation | Placebo comparator | This group will receive once a combination of Placebo (oral solution) and fear reactivation before exposure therapy. Receives: Drug: Placebo; Behavioral: Fear reactivation |
| Placebo and no fear reactivation | Placebo comparator | This group will receive once Placebo (oral solution) before exposure therapy. Receives: Drug: Placebo; Behavioral: No fear reactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance in Behavioral Approach Test (BAT) in real-life (in vivo)
Measured: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
Secondary outcomes (13)
Change in performance in BAT in virtual reality (in virtuo)
Measured: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
Change in subjective reactions in BAT in virtual reality (in virtuo)
Measured: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
Change in psychophysiological reactions in BAT in virtual reality (in virtuo)
Measured: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
Change in subjective reactions to fear-related picture cue presentation quantified by visual analog scales (VAS) for valence, arousal and fear
Measured: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
Change in psychophysiological reactions to fear-related picture cue presentation quantified by electrodermal activity (EDA), heart rate (HR), startle response
Measured: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention
Performance in working and recognition memory of pictures task
Measured: Follow up (visit 3: 90 days after visit 2: intervention)
Valence, arousal, and mood ratings of pictures of working and recognition memory of pictures task
Measured: Follow up (visit 3: 90 days after visit 2: intervention)
Change in strength of phobic fear quantified by self-report questionnaires
Measured: 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)
Change in mood and state-anxiety quantified by self-report questionnaires
Measured: 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)
Change in performance during exposure in virtuo quantified by eye tracking
Measured: Intervention (visit 2: 7-21 days after visit 1: baseline)
Change in subjective reactions during exposure in virtuo quantified by subjective units of discomfort (SUD) ratings
Measured: Intervention (visit 2: 7-21 days after visit 1: baseline)
Change in psychophysiological reactions during exposure in virtuo quantified by EDA and HR
Measured: Intervention (visit 2: 7-21 days after visit 1)
Change in clinical relevance of phobic symptoms measured by Diagnostic Interview for Psychiatric Disorders (DIPS), section for specific phobia
Measured: Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobia, SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique JF de Quervain, MD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789813
- Sponsor's protocol ID
- 2016DR2001
- Acronym
- VALPRO
- Status last verified
- Oct 2018
- First submitted
- 20 Apr 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02789813
- Acronym / sponsor ID
- VALPRO / 2016DR2001
- Conditions
- Phobia, Specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Valproic Acid and fear reactivation | Experimental | Drug: Valproic Acid, Behavioral: Fear reactivationThis group will receive once a combination of 500mg Valproic Acid (oral solution) and fear reactivation before exposure therapy. |
| Valproic Acid and no fear reactivation | Active comparator | Drug: Valproic Acid, Behavioral: No fear reactivationThis group will receive once 500mg Valproic Acid (oral solution) before exposure therapy. |
| Placebo and fear reactivation | Placebo comparator | Drug: Placebo, Behavioral: Fear reactivationThis group will receive once a combination of Placebo (oral solution) and fear reactivation before exposure therapy. |
| Placebo and no fear reactivation | Placebo comparator | Drug: Placebo, Behavioral: No fear reactivationThis group will receive once Placebo (oral solution) before exposure therapy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic AcidAlso: Orfiril®Once oral administration of 500mg before exposure therapy. | Drug | Valproic Acid and fear reactivation, Valproic Acid and no fear reactivation |
| PlaceboOnce oral administration of 500mg before exposure therapy. | Drug | Placebo and fear reactivation, Placebo and no fear reactivation |
| Fear reactivationFear reactivation before exposure therapy. | Behavioural | Placebo and fear reactivation, Valproic Acid and fear reactivation |
| No fear reactivationNo fear reactivation before exposure therapy. | Behavioural | Placebo and no fear reactivation, Valproic Acid and no fear reactivation |
Primary outcome
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
13 secondary outcomes
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
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
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
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
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
Performance in working and recognition memory of pictures task
Time frame: Follow up (visit 3: 90 days after visit 2: intervention)
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)
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)
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)
Change in performance during exposure in virtuo quantified by eye tracking
Time frame: Intervention (visit 2: 7-21 days after visit 1: baseline)
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)
Change in psychophysiological reactions during exposure in virtuo quantified by EDA and HR
Time frame: Intervention (visit 2: 7-21 days after visit 1)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique JF de Quervain, MD principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valproic Acid, Fear reactivation and No fear reactivation in people with Phobia, Specific, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.