Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

Obsessive-compulsive Disorder (OCD) Clinical Trial

— P-EX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01949753
• Other study ID #: PV4398
• Status: Recruiting
• Phase: Phase 2
• First received: September 20, 2013
• Last updated: August 2, 2017
• Start date: September 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Michael Kellner, MD, PhD
• Email: kellner[@]uke.uni-hamburg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder
• Obsessive-compulsive Disorder (OCD)

Intervention

Behavioral:
• Exposure therapy with pharmacological facilitation
Exposure with response prevention and pharmacological facilitation
• Exposure therapy
Exposure with response prevention without pharmacological facilitation

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure		During exposure therapy
Primary	Subjective units of distress (SUD)		During exposure therapy
Secondary	Low/high frequency index of heart rate variability (L/HFI)		During exposure therapy