SchizophreniaPhase 2NCT00615511
Efficacy of Pregnenolone in Patients With Schizophrenia
A Phase 2 study testing pregnenolone in people with Schizophrenia and Schizoaffective Disorder, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- pregnenolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2007to Dec 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Diagnosis of schizophrenia or schizoaffective disorder
- No new medication for past 3 months and stable dose for past 4 weeks
- SANS (Negative symptom) score of 20 or above
Who cannot join
- Significant dementia or head trauma.
- Seizure during past year.
- Substance dependence in past 6 months or positive urine drug screen.
- History of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers.
- Steroid metabolism disorder, e.g.Cushings or Addison's disease.
- Taking steroids other than birth control or post-menopausal hormones.
- Women who are pregnant or nursing.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Weill Medical College of Cornell University
New York, New York, 10065
University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare
Piscataway, New Jersey, 08854
Weill Medical College of Cornell University
White Plains, New York, 10605
About this study
Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.
Read the detailed description
Pregnenolone is a steroid health supplement which is readily available in health food stores. We are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. We do not require you to stop your existing treatment in order to enter the study. After four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- placebo pregnenolone, pregnenolone
- Keywords
- schizophrenia, schizoaffective disorder, negative symptoms, cognition
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo pregnenoloneDietary supplement
Sugar pill, taken twice a day
pregnenoloneDietary supplement
500mg in tablet form taken orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Approximately one third of subjects Receives: Dietary Supplement: placebo pregnenolone |
| Pregnenolone | Experimental | Not described Receives: Dietary Supplement: pregnenolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
SANS - Scale for the Assessment of Negative Symptoms
Measured: every month for 4 months
Secondary outcomes (1)
Quality of Life
Measured: every two months for four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Principal investigator, Jason Kim, Weill Medical College of Cornell University
- Investigators
- Jason J Kim, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615511
- Sponsor's protocol ID
- PRE0504007841
- Other IDs
- 05T-658
- Status last verified
- Dec 2015
- First submitted
- 1 Feb 2008
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pregnenolone in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00615511
- Acronym / sponsor ID
- PRE0504007841
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective disorder, negative symptoms, cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Jun 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Feb 2008 (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.
Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.
Detailed description
Pregnenolone is a steroid health supplement which is readily available in health food stores. We are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. We do not require you to stop your existing treatment in order to enter the study. After four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placebo pregnenoloneApproximately one third of subjects |
| Pregnenolone | Experimental | Dietary Supplement: pregnenolone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65
- Diagnosis of schizophrenia or schizoaffective disorder
- No new medication for past 3 months and stable dose for past 4 weeks
- SANS (Negative symptom) score of 20 or above
Key exclusion criteria (7 listed)
- Significant dementia or head trauma.
- Seizure during past year.
- Substance dependence in past 6 months or positive urine drug screen.
- History of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers.
- Steroid metabolism disorder, e.g.Cushings or Addison's disease.
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 |
|---|---|---|
| placebo pregnenoloneSugar pill, taken twice a day | Dietary supplement | placebo |
| pregnenolone500mg in tablet form taken orally twice a day | Dietary supplement | Pregnenolone |
Primary outcome
SANS - Scale for the Assessment of Negative Symptoms
Time frame: every month for 4 months
1 secondary outcome
Quality of Life
Time frame: every two months for four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
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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.
Jason J Kim, MD principal investigator
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pregnenolone in people with Schizophrenia and Schizoaffective Disorder, run by Weill Medical College of Cornell University at 3 sites in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SANS - Scale for the Assessment of Negative Symptoms (time frame: every month for 4 months). 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 21 Dec 2015.