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

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01949753
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 63
• Patients Per Site Per Month: 1

Study Details

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.

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Subjective units of distress (SUD) [During exposure therapy]

Secondary Outcome Measures

1. Low/high frequency index of heart rate variability (L/HFI) [During exposure therapy]

Other Outcome Measures

1. Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure [During exposure therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hamburg-Eppendorf	Hamburg		Germany

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf

Investigators

• Principal Investigator: Michael Kellner, MD, PhD, Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT01949753
• Other Study ID Numbers: PV4398
• First Posted: Sep 24, 2013
• Last Update Posted: Aug 3, 2017
• Last Verified: Aug 1, 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

Study Results

No Results Posted as of Aug 3, 2017