SchizophreniaPhase 3NCT00141947
Bexarotene Treatment in Schizophrenia
A Phase 3 study testing bexarotene (Targretin) in people with Schizophrenia, run by Beersheva Mental Health Center at 2 sites in Israel.
Trial summary
In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069; 4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) on severity of psychopathology, cognitive impairment, and quality of life in schizophrenia patients in an open label trial. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- bexarotene (Targretin)
- How many people
- 15 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2005to Sep 2006
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-60
- schizophrenia
- stable blood parameters
- normal baseline fasting triglyceride
- ability to sign informed consent
Who cannot join
- lipid abnormalities
- leukopenia or neutropenia
- organic brain damage (mental retardation)
- alcohol or drug abuse
- renal disease
- hepatic dysfunction
Show all 13Show fewer
- history of pancreatitis
- thyroid axis alterations
- suicide attempt in past year
- cataracts
- systemic treatment with more than 15,000IU vitamin A daily
- patients with known hypersensitivity to bexarotene or other components of the product
- pregnant women
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Beersheva Mental Health Center
Beersheva
Vladimir Lerner, MD, PhD, 972-8-6401408, lernervld@yahoo.com
Vladimir Lerner, MD, PhD
- Recruiting
Shaar Manashe Mental Health Center
Hadera
Michael Ritsner, MD, 9728-627-8750, ritsner@shaar-menashe.org.il
Michael Ritsner, MD
About this study
Official title: Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial
In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069; 4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) on severity of psychopathology, cognitive impairment, and quality of life in schizophrenia patients in an open label trial. The rationale behind add-on oral bexarotene to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis (Goodman, 1995) and the growth factors deficiency and synaptic destabilization hypothesis (Moises et al, 2002) of schizophrenia. In this clinical trial, a novel regimen of low dose bexarotene (Targretin, 75 mg/day) will be added for 6 weeks to the standard treatment of 15 schizophrenia patients on stable antipsychotic treatment. Participants will be assessed at baseline and after 2, 4 and 6 weeks of treatment. A battery of research instruments will be used for assessment of efficacy and safety (psychopathology, and side effects). In addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during therapy.
- Conditions
- Schizophrenia
- Being tested
- bexarotene (Targretin)
- Keywords
- bexarotene, schizophrenia, psychopathology, cognitive impairment, quality of life, open lable trial
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bexarotene (Targretin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Schedule for Assessment of Mental Disorder
The Positive and Negative Syndrome Scale
Montgomery and Äsberg Depression Rating Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2005
- Study completionSep 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beersheva Mental Health Center
- Sponsor type
- Other government
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Principal investigator, Vladimir Lerner, Beersheva Mental Health Center
- Investigators
- Vladimir Lerner, MD, PhD, Principal investigator, Ben-Gurion University of the NegevMichael Ritsner, MD, Principal investigator, Technion-Israel Institute of Technology (Haifa)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141947
- Sponsor's protocol ID
- BMHC-3775
- Status last verified
- Oct 2005
- First submitted
- 1 Sep 2005
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lerner V, Miodownik C, Gibel A, Kovalyonok E, Shleifer T, Goodman AB, Ritsner MS. Bexarotene as add-on to antipsychotic treatment in schizophrenia patients: a pilot open-label trial. Clin Neuropharmacol. 2008 Jan-Feb;31(1):25-33. doi: 10.1097/WNF.0b013e31806450da.
PubMed 18303488
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial
- ClinicalTrials.gov ID
- NCT00141947
- Acronym / sponsor ID
- BMHC-3775
- Conditions
- Schizophrenia
- Keywords
- bexarotene, schizophrenia, psychopathology, cognitive impairment, quality of life, open lable trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beersheva Mental Health CenterOther government
- Collaborators
- Stanley Medical Research Institute
- Study start
- Sep 2005
- Study completion
- Sep 2006
- First posted
- 2 Sep 2005 (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.
In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069; 4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) on severity of psychopathology, cognitive impairment, and quality of life in schizophrenia patients in an open label trial. The rationale behind add-on oral bexarotene to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis (Goodman, 1995) and the growth factors deficiency and synaptic destabilization hypothesis (Moises et al, 2002) of schizophrenia. In this clinical trial, a novel regimen of low dose bexarotene (Targretin, 75 mg/day) will be added for 6 weeks to the standard treatment of 15 schizophrenia patients on stable antipsychotic treatment. Participants will be assessed at baseline and after 2, 4 and 6 weeks of treatment. A battery of research instruments will be used for assessment of efficacy and safety (psychopathology, and side effects). In addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 18-60
- schizophrenia
- stable blood parameters
- normal baseline fasting triglyceride
- ability to sign informed consent
Key exclusion criteria (13 listed)
- lipid abnormalities
- leukopenia or neutropenia
- organic brain damage (mental retardation)
- alcohol or drug abuse
- renal 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 |
|---|---|---|
| bexarotene (Targretin) | Drug | – |
Primary outcome
Schedule for Assessment of Mental Disorder
The Positive and Negative Syndrome Scale
Montgomery and Äsberg Depression Rating Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
- Derived from this study: PubMed 18303488Lerner V, Miodownik C, Gibel A, Kovalyonok E, Shleifer T, Goodman AB, Ritsner MS. Bexarotene as add-on to antipsychotic treatment in schizophrenia patients: a pilot open-label trial. Clin Neuropharmacol. 2008 Jan-Feb;31(1):25-33. doi: 10.1097/WNF.0b013e31806450da.
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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.
Vladimir Lerner, MD, PhD principal investigator
Ben-Gurion University of the Negev
Michael Ritsner, MD principal investigator
Technion-Israel Institute of Technology (Haifa)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bexarotene (Targretin) in people with Schizophrenia, run by Beersheva Mental Health Center at 2 sites 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 5 inclusion and 13 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 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Vladimir Lerner, MD, PhD (972-8-6401408, lernervld@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schedule for Assessment of Mental Disorder. The study lists 3 primary outcomes in all. 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 NCT00141947, 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 24 Jul 2013.