A Phase 2 interventional study of Exposure therapy with pharmacological facilitation and Exposure therapy in Obsessive-compulsive Disorder (OCD), sponsored by Universitätsklinikum Hamburg-Eppendorf. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-03.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 2, Interventional, and Basic science
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.
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
626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.
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-OCD according to DSM-IV criteria.
Exclusion Criteria:
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 therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy.
Behavioral: Exposure therapy
Exposure with response prevention and pharmacological facilitation
Exposure with response prevention without pharmacological facilitation
Subjective units of distress (SUD)
Time frame: During exposure therapy
Low/high frequency index of heart rate variability (L/HFI)
Time frame: During exposure therapy
Salivary cortisol, noradrenaline, pregnenolone; heart rate, blood pressure
Time frame: During exposure therapy
The record gives a start of Sep 2013, a primary completion of Dec 2017 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Obsessive-Compulsive Disorder →
Universitätsklinikum Hamburg-Eppendorf →