Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

Phase 2UnknownNCT01949753

Universitätsklinikum Hamburg-Eppendorf60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Obsessive-compulsive Disorder (OCD)

Interventions

Exposure therapy with pharmacological facilitationBEHAVIORAL

Exposure with response prevention and pharmacological facilitation

Exposure therapyBEHAVIORAL

Exposure with response prevention without pharmacological facilitation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Outcomes

Primary Outcomes

Subjective units of distress (SUD)

Time frame: During exposure therapy

Secondary Outcomes

Low/high frequency index of heart rate variability (L/HFI)

Time frame: During exposure therapy

Central Contacts

Michael Kellner, MD, PhD

CONTACT

kellner@uke.uni-hamburg.de

Data from ClinicalTrials.gov

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