Obsessive-compulsive Disorder (OCD)Phase 2P-EXNCT01949753
Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder
A Phase 2 study testing Exposure therapy with pharmacological facilitation and Exposure therapy in people with Obsessive-compulsive Disorder (OCD), run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obsessive-compulsive Disorder (OCD)
- What is being tested?
- Exposure therapy with pharmacological facilitation and Exposure therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -OCD according to DSM-IV criteria.
Who cannot join
- Acute suicidality
- psychotic disorders,
- bipolar disorder
- substance dependency
- organic brain disorder
- pregnancy
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- lactation
- tuberculosis
- gastric/duodenal ulcer
- diabetes mellitus
- acute inflammation
- autoimmune disorders
- arterial hypertension
- therapy with glucocorticoids (up to 4 weeks ago)
Trial locations and contacts
1 site in 1 country.
Michael Kellner, MD, PhD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Hamburg-Eppendorf
Hamburg
Michael Kellner, MD, PhD
About this study
Official title: Influence of Pregnenolone on Distress and Autonomic Parameters During Cognitive-behavioral Exposure Therapy in Patients With Obsessive-compulsive Disorder
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.
Read the 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
- Conditions
- Obsessive-compulsive Disorder (OCD)
- Being tested
- Exposure therapy with pharmacological facilitation, Exposure therapy
- Keywords
- Obsessive-compulsive disorder (OCD), Exposure therapy, Extinction learning, Pregnenolone
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure therapy with pharmacological facilitationBehavioural
Exposure with response prevention and pharmacological facilitation
Exposure therapyBehavioural
Exposure with response prevention without pharmacological facilitation
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplement Pregnenolone | Experimental | Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy. Receives: Behavioral: Exposure therapy with pharmacological facilitation |
| Placebo | Placebo comparator | Exposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy. Receives: Behavioral: Exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective units of distress (SUD)
Measured: During exposure therapy
Secondary outcomes (1)
Low/high frequency index of heart rate variability (L/HFI)
Measured: During exposure therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kellner, MD, PhD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949753
- Sponsor's protocol ID
- PV4398
- Acronym
- P-EX
- Status last verified
- Aug 2017
- First submitted
- 20 Sep 2013
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pregnenolone on Distress and Autonomic Parameters During Cognitive-behavioral Exposure Therapy in Patients With Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT01949753
- Acronym / sponsor ID
- P-EX / PV4398
- Conditions
- Obsessive-compulsive Disorder (OCD)
- Keywords
- Obsessive-compulsive disorder (OCD), Exposure therapy, Extinction learning, Pregnenolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplement Pregnenolone | Experimental | Behavioral: Exposure therapy with pharmacological facilitationExposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy. |
| Placebo | Placebo comparator | Behavioral: Exposure therapyExposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -OCD according to DSM-IV criteria.
Key exclusion criteria (14 listed)
- Acute suicidality
- psychotic disorders,
- bipolar disorder
- substance dependency
- organic brain disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure therapy with pharmacological facilitationExposure with response prevention and pharmacological facilitation | Behavioural | Nutritional supplement Pregnenolone |
| Exposure therapyExposure with response prevention without pharmacological facilitation | Behavioural | Placebo |
Primary outcome
Subjective units of distress (SUD)
Time frame: During exposure therapy
1 secondary outcome
Low/high frequency index of heart rate variability (L/HFI)
Time frame: During exposure therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kellner, MD, PhD contact
Michael Kellner, MD, PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exposure therapy with pharmacological facilitation and Exposure therapy in people with Obsessive-compulsive Disorder (OCD), run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Kellner, MD, PhD (kellner@uke.uni-hamburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective units of distress (SUD) (time frame: During exposure therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.