Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

NCT ID: NCT01949753

Last Updated: 2017-08-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Obsessive-compulsive Disorder (OCD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

Exposure therapy with pharmacological facilitation

Intervention Type BEHAVIORAL

Exposure with response prevention and pharmacological facilitation

Placebo

Exposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy.

Group Type PLACEBO_COMPARATOR

Exposure therapy

Intervention Type BEHAVIORAL

Exposure with response prevention without pharmacological facilitation

Interventions

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Exposure therapy with pharmacological facilitation

Exposure with response prevention and pharmacological facilitation

Intervention Type BEHAVIORAL

Exposure therapy

Exposure with response prevention without pharmacological facilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Kellner, MD, PhD

Role: CONTACT

Other Identifiers

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PV4398

Identifier Type: -

Identifier Source: org_study_id

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