SchizophreniaPhase 4PREG-2008NCT00847600
Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia
A Phase 4 study testing Pregnenolone in people with Schizophrenia and Schizophreniform Disorder, run by Sha'ar Menashe Mental Health Center at 1 site in Israel.
Trial summary
Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous system, and may be beneficial in the treatment of patients with schizophrenia. Our recent 8-week, randomized, double-blind trial among patients with chronic schizophrenia and schizoaffective disorders, in which PREG versus… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorders
- What is being tested?
- Pregnenolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Dec 2010
- Phase
- Phase 4
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years of age, any ethnic group, either sex.
- DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorders (36).
- Duration of illness less than 5 years since onset first psychotic episode.
- Subjects entering the study must score at least 4 on the Clinical Global Impression Scale.
- At least two weeks of ongoing treatment with current antipsychotic agents during the pre-treatment stabilization period.
- Stable symptoms throughout the 2-week pre-treatment stabilization period. Clinical stability is defined as two consecutive weekly CGI ratings with no change in score, and with no more than a 20% change in PANSS total score.
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- No change in anticholinergic, benzodiazepine, or mood stabilizer medications for the pre-treatment stabilization period.
- No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 8-week duration of the study.
- Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Who cannot join
- Evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, Cushings disease, or thyroid disorder, mental retardation, alcohol or drug abuse, substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
- Unstable medical illness or neurologic illness (seizures, CVA); history of prostate, breast, uterine, or ovarian cancer.
- Pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen.
- Current active suicidal and/or homicidal ideation, intent, or plan.
- Known allergy to study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia: an 8-week, Randomized, Double-blind, Placebo-controlled Trial
Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous system, and may be beneficial in the treatment of patients with schizophrenia. Our recent 8-week, randomized, double-blind trial among patients with chronic schizophrenia and schizoaffective disorders, in which PREG versus placebo and DHEA have been added to conventional or atypical antipsychotics have yielded encouraging results with low-dose PREG (30 mg/day; ClinicalTrials.gov identifier NCT00140192; Ritsner et al., in press). The goal of the present study is to evaluate the potential role of PREG's augmentation compared to placebo in the treatment of young patients with newly diagnosed schizophrenia or schizophreniform or schizoaffective disorders.
In a 8-week, randomized, double-blind placebo-controlled trial PREG (50 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 60 patients with recent-onset schizophrenia or schizophreniform or schizoaffective disorders. Participants will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research instruments will be used for assessment of psychopathology, cognitive functions, side effects, general functioning and quality of life. In addition blood PREG levels will be monitored at baseline and during the study. The study is powered to detect moderate between-group effects on persistent positive, negative and cognitive symptoms.
- Being tested
- Pregnenolone, Placebo
- Keywords
- Schizophrenia, Neurosteroids, Pregnenolone, Augmentation
- 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.
PregnenoloneDietary supplement
50 mg, caps.
PlaceboDietary supplement
caps
| Study group | Role | What they receive |
|---|---|---|
| 1 Pregnenolone | Experimental | 50 mg/day Receives: Dietary Supplement: Pregnenolone |
| 2 Placebo | Placebo comparator | 1 caps. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinical Global Impression Scale (CGI-S) The Positive and Negative Syndrome Scale (PANSS) The Scale for the Assessment of Negative Symptoms (SANS)
Measured: baseline, 2, 4, 6, and 8 weeks
Secondary outcomes (3)
Global Assessment of Functioning
Measured: baseline, 2, 4, 6, and 8 weeks
The Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: baseline, 4 and 8 weeks
Extrapyramidal Symptom Rating Scale
Measured: baseline, 2, 4, 6, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sha'ar Menashe Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tirat Carmel Mental Health Center
- Investigators
- Michael S Ritsher, MD, PhD, Study chair, Technion and Shaar Menashe MHCAnatoly Kreinin, MD, PhD, Study director, Technion and Tirat Carmel Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847600
- Sponsor's protocol ID
- MEN-8-11-08
- Other IDs
- 08TGF-1189 Stanley grant
- Acronym
- PREG-2008
- Status last verified
- Dec 2010
- First submitted
- 18 Feb 2009
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ritsner M, Maayan R, Gibel A, Weizman A. Differences in blood pregnenolone and dehydroepiandrosterone levels between schizophrenia patients and healthy subjects. Eur Neuropsychopharmacol. 2007 Apr;17(5):358-65. doi: 10.1016/j.euroneuro.2006.10.001. Epub 2006 Nov 21.
PubMed 17123790
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia: an 8-week, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00847600
- Acronym / sponsor ID
- PREG-2008 / MEN-8-11-08
- Keywords
- Schizophrenia, Neurosteroids, Pregnenolone, Augmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sha'ar Menashe Mental Health CenterUniversity, hospital or other
- Collaborators
- Tirat Carmel Mental Health Center
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Feb 2009 (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.
Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous system, and may be beneficial in the treatment of patients with schizophrenia. Our recent 8-week, randomized, double-blind trial among patients with chronic schizophrenia and schizoaffective disorders, in which PREG versus placebo and DHEA have been added to conventional or atypical antipsychotics have yielded encouraging results with low-dose PREG (30 mg/day; ClinicalTrials.gov identifier NCT00140192; Ritsner et al., in press). The goal of the present study is to evaluate the potential role of PREG's augmentation compared to placebo in the treatment of young patients with newly diagnosed schizophrenia or schizophreniform or schizoaffective disorders.
In a 8-week, randomized, double-blind placebo-controlled trial PREG (50 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 60 patients with recent-onset schizophrenia or schizophreniform or schizoaffective disorders. Participants will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research instruments will be used for assessment of psychopathology, cognitive functions, side effects, general functioning and quality of life. In addition blood PREG levels will be monitored at baseline and during the study. The study is powered to detect moderate between-group effects on persistent positive, negative and cognitive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Pregnenolone | Experimental | Dietary Supplement: Pregnenolone50 mg/day |
| 2 Placebo | Placebo comparator | Dietary Supplement: Placebo1 caps. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18-40 years of age, any ethnic group, either sex.
- DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorders (36).
- Duration of illness less than 5 years since onset first psychotic episode.
- Subjects entering the study must score at least 4 on the Clinical Global Impression Scale.
- At least two weeks of ongoing treatment with current antipsychotic agents during the pre-treatment stabilization period.
Key exclusion criteria (5 listed)
- Evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, Cushings disease, or thyroid disorder, mental retardation, alcohol or drug abuse, substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
- Unstable medical illness or neurologic illness (seizures, CVA); history of prostate, breast, uterine, or ovarian cancer.
- Pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen.
- Current active suicidal and/or homicidal ideation, intent, or plan.
- Known allergy to study medication.
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 |
|---|---|---|
| Pregnenolone50 mg, caps. | Dietary supplement | 1 Pregnenolone |
| Placebocaps | Dietary supplement | 2 Placebo |
Primary outcome
The Clinical Global Impression Scale (CGI-S) The Positive and Negative Syndrome Scale (PANSS) The Scale for the Assessment of Negative Symptoms (SANS)
Time frame: baseline, 2, 4, 6, and 8 weeks
3 secondary outcomes
Global Assessment of Functioning
Time frame: baseline, 2, 4, 6, and 8 weeks
The Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: baseline, 4 and 8 weeks
Extrapyramidal Symptom Rating Scale
Time frame: baseline, 2, 4, 6, and 8 weeks
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 15 Dec 2010.
- Background: PubMed 17123790Ritsner M, Maayan R, Gibel A, Weizman A. Differences in blood pregnenolone and dehydroepiandrosterone levels between schizophrenia patients and healthy subjects. Eur Neuropsychopharmacol. 2007 Apr;17(5):358-65. doi: 10.1016/j.euroneuro.2006.10.001. Epub 2006 Nov 21.
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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 S Ritsher, MD, PhD study chair
Technion and Shaar Menashe MHC
Anatoly Kreinin, MD, PhD study director
Technion and Tirat Carmel Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregnenolone in people with Schizophrenia and Schizophreniform Disorder, run by Sha'ar Menashe Mental Health Center at 1 site in Israel.
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 9 inclusion and 5 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 15 Dec 2010. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The Clinical Global Impression Scale (CGI-S) The Positive and Negative Syndrome Scale (PANSS) The Scale for the Assessment of Negative Symptoms (SANS) (time frame: baseline, 2, 4, 6, and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00847600, which also lists 1 linked publication.
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 15 Dec 2010.