Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

Phase 2

• Conditions: Obsessive-compulsive Disorder (OCD)

• Registration Number: NCT01949753
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

-OCD according to DSM-IV criteria.

Exclusion Criteria

• Acute suicidality
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective units of distress (SUD)	During exposure therapy

Secondary Outcome Measures

Name	Time	Method
Low/high frequency index of heart rate variability (L/HFI)	During exposure therapy

Trial Locations

Locations (1)

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany