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

Universitätsklinikum Hamburg-Eppendorf

Status and phase

Unknown

Phase 2

Conditions

Obsessive-compulsive Disorder (OCD)

Treatments

Behavioral: Exposure therapy

Behavioral: Exposure therapy with pharmacological facilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT01949753

PV4398

Details and patient eligibility

About

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.

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Nutritional supplement Pregnenolone

Experimental group

Description:

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

Treatment:

Behavioral: Exposure therapy with pharmacological facilitation

Placebo

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Exposure therapy