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

Primary Purpose

Obsessive-compulsive Disorder (OCD)

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Exposure therapy with pharmacological facilitation

Exposure therapy

About this trial

This is an interventional basic science trial for Obsessive-compulsive Disorder (OCD) focused on measuring Obsessive-compulsive disorder (OCD), Exposure therapy, Extinction learning, Pregnenolone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University Hospital Hamburg-EppendorfRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutritional supplement Pregnenolone

Placebo

Arm Description

Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy.

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

Outcomes

Primary Outcome Measures

Subjective units of distress (SUD)

Secondary Outcome Measures

Low/high frequency index of heart rate variability (L/HFI)

Full Information

NCT ID

NCT01949753

First Posted

September 20, 2013

Last Updated

August 2, 2017

Sponsor

Universitätsklinikum Hamburg-Eppendorf

1. Study Identification

Unique Protocol Identification Number

NCT01949753

Brief Title

Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

Acronym

P-EX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-compulsive Disorder (OCD)

Keywords

Obsessive-compulsive disorder (OCD), Exposure therapy, Extinction learning, Pregnenolone

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nutritional supplement Pregnenolone

Arm Type

Experimental

Arm Description

Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exposure therapy with pharmacological facilitation

Intervention Description

Exposure with response prevention and pharmacological facilitation

Intervention Type

Behavioral

Intervention Name(s)

Exposure therapy

Intervention Description

Exposure with response prevention without pharmacological facilitation

Primary Outcome Measure Information:

Title

Subjective units of distress (SUD)

Time Frame

During exposure therapy

Secondary Outcome Measure Information:

Title

Low/high frequency index of heart rate variability (L/HFI)

Time Frame

During exposure therapy

Other Pre-specified Outcome Measures:

Title

Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure

Time Frame

During exposure therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Kellner, MD, PhD

kellner@uke.uni-hamburg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Kellner, MD, PhD

Organizational Affiliation

Universitätsklinikum Hamburg-Eppendorf

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Hamburg-Eppendorf

City

Hamburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Kellner, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

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