Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder (P-EX)

August 2, 2017 updated by: Universitätsklinikum Hamburg-Eppendorf

Influence of Pregnenolone on Distress and Autonomic Parameters During Cognitive-behavioral Exposure Therapy in Patients With Obsessive-compulsive Disorder

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Recruiting
        • University Hospital Hamburg-Eppendorf
        • Principal Investigator:
          • Michael Kellner, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional supplement Pregnenolone
Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy.
Behavioral: Exposure therapy with pharmacological facilitation
Exposure with response prevention and pharmacological facilitation
Placebo Comparator: Placebo
Exposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy.
Behavioral: Exposure therapy
Exposure with response prevention without pharmacological facilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective units of distress (SUD)
Time Frame: During exposure therapy
During exposure therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Low/high frequency index of heart rate variability (L/HFI)
Time Frame: During exposure therapy
During exposure therapy

Other Outcome Measures

Outcome Measure
Time Frame
Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure
Time Frame: During exposure therapy
During exposure therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Michael Kellner, MD, PhD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV4398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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