Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder
NCT ID: NCT01949753
Last Updated: 2017-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2013-09-30
2018-12-31
Brief Summary
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Detailed Description
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Inter-session habituation as per SUD (100 mm VAS), Y-BOCS
Secondary out-come parameter:
HF/LF of HRV, Salivary epinephrine
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Nutritional supplement Pregnenolone
Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy.
Exposure therapy with pharmacological facilitation
Exposure with response prevention and pharmacological facilitation
Placebo
Exposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy.
Exposure therapy
Exposure with response prevention without pharmacological facilitation
Interventions
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Exposure therapy with pharmacological facilitation
Exposure with response prevention and pharmacological facilitation
Exposure therapy
Exposure with response prevention without pharmacological facilitation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* psychotic disorders,
* bipolar disorder
* substance dependency
* organic brain disorder
* pregnancy
* lactation
* tuberculosis
* gastric/duodenal ulcer
* diabetes mellitus
* acute inflammation
* autoimmune disorders
* arterial hypertension
* therapy with glucocorticoids (up to 4 weeks ago)
18 Years
80 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Michael Kellner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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University Hospital Hamburg-Eppendorf
Hamburg, , Germany
Countries
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Central Contacts
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Other Identifiers
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PV4398
Identifier Type: -
Identifier Source: org_study_id
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