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

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ClinicalTrials.gov Identifier: NCT01949753
Recruitment Status : Recruiting
First Posted : September 24, 2013
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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 or disease Intervention/treatment Phase
Obsessive-compulsive Disorder (OCD) Behavioral: Exposure therapy with pharmacological facilitation Behavioral: Exposure therapy Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Subjective units of distress (SUD) [ Time Frame: During exposure therapy ]

Secondary Outcome Measures :
  1. Low/high frequency index of heart rate variability (L/HFI) [ Time Frame: During exposure therapy ]

Other Outcome Measures:
  1. Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure [ Time Frame: During exposure therapy ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01949753     History of Changes
Other Study ID Numbers: PV4398
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

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

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