Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

Phase 2

• Conditions: Obsessive-compulsive Disorder (OCD)
• Interventions: Behavioral: Exposure therapy; Behavioral: Exposure therapy with pharmacological facilitation

• 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

Arm && Interventions

Group	Intervention	Description
Placebo	Exposure therapy	Exposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy.
Nutritional supplement Pregnenolone	Exposure therapy with pharmacological facilitation	Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy.

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