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Characterization of the influence of pregnenolone vs. placebo on subjective distress and autonomic functioning during cognitive-behavioral exposure therapy in patients with obsessive-compulsive disorder.
Main out-come parameters:
Inter-session habituation as per SUD (100 mm VAS), Y-BOCS
Secondary out-come parameter:
HF/LF of HRV, Salivary epinephrine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional supplement Pregnenolone | Experimental | Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy. |
|
| Placebo | Placebo Comparator | Exposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure therapy with pharmacological facilitation | Behavioral | Exposure with response prevention and pharmacological facilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective units of distress (SUD) | During exposure therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Low/high frequency index of heart rate variability (L/HFI) | During exposure therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure | During exposure therapy |
Inclusion Criteria:
-OCD according to DSM-IV criteria.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Kellner, MD, PhD | Contact | kellner@uke.uni-hamburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael Kellner, MD, PhD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Exposure therapy | Behavioral | Exposure with response prevention without pharmacological facilitation |
|