Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01949753

Acronym

P-EX

Enrollment

Registered

2013-09-24

Start date

2013-09-30

Completion date

2018-12-31

Last updated

2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-compulsive Disorder (OCD)

Keywords

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

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

Interventions

BEHAVIORALExposure therapy with pharmacological facilitation

Exposure with response prevention and pharmacological facilitation

BEHAVIORALExposure therapy

Exposure with response prevention without pharmacological facilitation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame
Subjective units of distress (SUD)	During exposure therapy

Secondary

Measure	Time frame
Low/high frequency index of heart rate variability (L/HFI)	During exposure therapy

Other

Measure	Time frame
Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure	During exposure therapy

Countries

Germany

Contacts

Primary ContactMichael Kellner, MD, PhD

kellner@uke.uni-hamburg.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026