Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder
P-EX
Influence of Pregnenolone on Distress and Autonomic Parameters During Cognitive-behavioral Exposure Therapy in Patients With Obsessive-compulsive Disorder
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 20, 2013
CompletedFirst Posted
Study publicly available on registry
September 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 3, 2017
August 1, 2017
4.3 years
September 20, 2013
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective units of distress (SUD)
During exposure therapy
Secondary Outcomes (1)
Low/high frequency index of heart rate variability (L/HFI)
During exposure therapy
Other Outcomes (1)
Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure
During exposure therapy
Study Arms (2)
Nutritional supplement Pregnenolone
EXPERIMENTALExposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy.
Placebo
PLACEBO COMPARATORExposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy.
Interventions
Exposure with response prevention and pharmacological facilitation
Exposure with response prevention without pharmacological facilitation
Eligibility Criteria
You may qualify if:
- OCD according to DSM-IV criteria.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Hamburg-Eppendorf
Hamburg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Kellner, MD, PhD
Universitätsklinikum Hamburg-Eppendorf
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2013
First Posted
September 24, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
August 3, 2017
Record last verified: 2017-08