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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Compulsive Personality Disorder
Disease
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes
Personality Disorders

ClinicalTrials.gov processed this record on November 25, 2014