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

This study is currently recruiting participants.
Verified September 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01949753
First received: September 20, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Obsessive-compulsive Disorder (OCD)
Dietary Supplement: Pregnenolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Influence of Pregnenolone on Distress and Autonomic Parameters During Cognitive-behavioral Exposure Therapy in Patients With Obsessive-compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Subjective units of distress (SUD) [ Time Frame: During exposure therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Low/high frequency index of heart rate variability (L/HFI) [ Time Frame: During exposure therapy ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Salivary cortisol, noradrealine, pregnenolone; heart rate, blood pressure [ Time Frame: During exposure therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional supplement Pregnenolone
Orally two hours before exposure therapy.
Dietary Supplement: Pregnenolone
Placebo Comparator: Nutritional supplement Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01949753

Contacts
Contact: Michael Kellner, MD, PhD kellner@uke.uni-hamburg.de

Locations
Germany
University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany
Principal Investigator: Michael Kellner, MD, PhD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Michael Kellner, MD, PhD Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01949753     History of Changes
Other Study ID Numbers: PV4398
Study First Received: September 20, 2013
Last Updated: September 23, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Obsessive-compulsive disorder (OCD)
Exposure therapy
Extinction learning
Pregnenolone

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on April 17, 2014