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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Valproic Acid and no fear reactivation | Active Comparator | This group will receive once 500mg Valproic Acid (oral solution) before exposure therapy. |
|
| Placebo and fear reactivation | Placebo Comparator | This group will receive once a combination of Placebo (oral solution) and fear reactivation before exposure therapy. |
|
| Placebo and no fear reactivation | Placebo Comparator | This group will receive once Placebo (oral solution) before exposure therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproic Acid | Drug | Once oral administration of 500mg before exposure therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique JF de Quervain, MD | University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric University Clinics, University Basel | Basel | 4012 | Switzerland |
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| ID | Term |
|---|---|
| C562465 | Phobia, Specific |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Placebo | Drug | Once oral administration of 500mg before exposure therapy. |
|
| Fear reactivation | Behavioral | Fear reactivation before exposure therapy. |
|
| No fear reactivation | Behavioral | No fear reactivation before exposure therapy. |
|
| 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 |
| Performance in working and recognition memory of pictures task | 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 | Follow up (visit 3: 90 days after visit 2: intervention) |
| Change in strength of phobic fear quantified by self-report questionnaires | 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 | 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 | 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 | Intervention (visit 2: 7-21 days after visit 1: baseline) |
| Change in psychophysiological reactions during exposure in virtuo quantified by EDA and HR | 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 | Baseline (visit 1: 7-21 days before visit 2: intervention) 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) |
| VAS of headache, stomach pain, nausea, fatigue, dizziness, drowsiness muscle fatigue, and motivation. | 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) |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |