- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01949753
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 Contact
- Name: Michael Kellner, MD, PhD
- Email: kellner@uke.uni-hamburg.de
Study Locations
-
-
-
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.
|
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.
|
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.
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
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.
Clinical Trials on Obsessive-compulsive Disorder (OCD)
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)RecruitingObsessive Compulsive Disorder (OCD)United States
-
University of ArizonaActive, not recruitingObsessive-compulsive Disorder (OCD)United States
-
University of LeipzigGerman Research Foundation; Philipps University Marburg Medical CenterCompleted
-
New York State Psychiatric InstituteCompletedObsessive-Compulsive Disorder (OCD)United States
-
Baylor College of MedicineBrown University; Duke University; University of Washington; Mclean Hospital; William... and other collaboratorsNot yet recruitingObsessive-Compulsive Disorder (OCD)United States
-
New York State Psychiatric InstituteCompletedObsessive Compulsive Disorder (OCD)United States
-
The University of Texas Health Science Center,...MedtronicRecruitingObsessive-Compulsive Disorder (OCD)United States
-
Haukeland University HospitalSorlandet Hospital HFActive, not recruitingObsessive Compulsive Disorder (OCD)
-
University of BathSouth London and Maudsley NHS Foundation Trust; Avon and Wiltshire Mental Health...UnknownObsessive Compulsive Disorder (OCD)United Kingdom
-
Assistance Publique - Hôpitaux de ParisRecruitingObsessive Compulsive Disorder OCDFrance
Clinical Trials on Exposure therapy with pharmacological facilitation
-
University of Texas at AustinNational Institute of Mental Health (NIMH)CompletedSpecific PhobiaUnited States
-
Riphah International UniversityCompleted
-
Karolinska InstitutetCompletedIrritable Bowel Syndrome
-
Region of Southern DenmarkUniversite du Quebec en OutaouaisCompleted
-
Assistance Publique Hopitaux De MarseilleRecruitingPTSD | Depression, Anxiety | Transplantation, LungFrance
-
University of Texas at AustinTerminated
-
Region of Southern DenmarkOdense University Hospital; University of Southern Denmark; Universite du Quebec... and other collaboratorsActive, not recruitingSocial Anxiety | Social PhobiaDenmark
-
Medical University of LublinCompleted
-
VA Office of Research and DevelopmentCompleted
-
Mental Health Services in the Capital Region, DenmarkRecruitingSocial Anxiety Disorder | AgoraphobiaDenmark