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

NCT02789813 | Completed Phase 2 DMC

• 1 other identifier: 2016DR2001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobia, Specific

Outcome Measures

Primary Outcomes (1)

• Change in performance in Behavioral Approach Test (BAT) in real-life (in vivo)

  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)

  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)

  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)

  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

  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

  Baseline (visit 1: 7-21 days before visit 2: intervention) and follow up (visit 3: 90 days after visit 2: intervention

Other Outcomes (4)

• Adverse Events

  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)

• Blood pressure

  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)

• Heart rate

  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)

Study Arms (4)

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.

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.

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.

Drug: Placebo; Behavioral: Fear reactivation

Placebo and no fear reactivation

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: No fear reactivation

Interventions

Valproic Acid DRUG

Once oral administration of 500mg before exposure therapy.

Also known as: Orfiril®

Valproic Acid and fear reactivation; Valproic Acid and no fear reactivation

Placebo DRUG

Once oral administration of 500mg before exposure therapy.

Placebo and fear reactivation; Placebo and no fear reactivation

Fear reactivation BEHAVIORAL

Fear reactivation before exposure therapy.

Placebo and fear reactivation; Valproic Acid and fear reactivation

No fear reactivation BEHAVIORAL

No fear reactivation before exposure therapy.

Placebo and no fear reactivation; Valproic Acid and no fear reactivation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead

Study Sites (1)

Psychiatric University Clinics, University Basel

Basel, 4012, Switzerland

Location

MeSH Terms

Conditions

Phobia, Specific

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Dominique JF de Quervain, MD

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: June 3, 2016
• Study Start: July 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)