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Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder (RAL-S-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280305
Recruitment Status : Unknown
Verified January 2011 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 20, 2011
Last Update Posted : January 20, 2011
Information provided by:
Sheba Medical Center

Brief Summary:
The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: raloxifene Drug: placebo Phase 3

Detailed Description:
Epidemiological evidence shows a potentially protective role for estrogen in women with schizophrenia. The onset of schizophrenia is later in woman than in men, with generally a less severe course until after the menopause, when for many women, reductions in estrogen levels appear to trigger an exacerbation or illness (Hafner 2003). ERα (Estrogen receptor alpha) expression is known to be reduced in schizophrenia (Wong, Woon et al. 2010). Raloxifene is a selective estrogen receptor modulator that acts as an estrogen antagonist in breast tissue and may have agonistic actions in the brain. Several studies (Kulkarni, Riedel et al. 2001; Chua, de Izquierdo et al. 2005; Kulkarni, Gurvich et al. 2010) indicate that treatment with estrogen and raloxifene improves symptoms in females with schizophrenia, and recently they showed an improvement in PANSS score in post menopausal women with schizophrenia receiving 60-120mg/d of raloxifene compared to placebo

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Administering Raloxifene vs Placebo as add-on to Antipsychotics in Post Menopausal Patients With Schizophrenia or Schizoaffective Disorder
Study Start Date : March 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Raloxifene

Arm Intervention/treatment
Experimental: raloxifene Drug: raloxifene
raloxifene 60 mg bid

Placebo Comparator: Placebo Drug: placebo
Placebo bid

Primary Outcome Measures :
  1. PANSS total score at the end of the trial. [ Time Frame: 3 times ]
    PANSS will be assesed at weeks 5, 8 and end of study.

Secondary Outcome Measures :
  1. PANSS,CGI-S, CGI-I, BACS and rates of drop outs before the end of the trial. [ Time Frame: PANSS 3 times, CGI-S and CGI-I 5 times and BACS 2 times ]
    PANSS will be assessed at week 5, 8, and end of study; CGI-S, CGI-I, will be assessed at week 2, 5, 8, 12, and end of study; BACS will be assessed at week 8 and end of study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Post menopausal females: Post menopausal defined as: Women 45 years of age and older with no vaginal bleeding for at least 2 years prior to randomization, and both serum estradiol <73 pmol/L (20 pg/mL) and FSH >30 IU/L (30 mIU/mL).
  2. 45-65 years old
  3. Willing and able to provide informed consent, after the nature of the study has been fully explained.
  4. Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months.
  5. Symptoms: 4 (moderate) or above on CGI-S and 4 (moderate) score or above on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution, and/or a total PANSS negative symptoms score of 18.
  6. Must be on any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to insure that the dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
  7. Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission.

Exclusion Criteria:

  1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
  2. Women of child bearing potential.
  3. Women who have amenorrhea due to causes other than natural or surgical menopause i.e. eating disorders or exercise
  4. Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning.
  5. Patients treated with cholestyramine, warfarin or concurrent systemic estrogen therapy
  6. Likely allergy or sensitivity to raloxifene.
  7. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
  8. Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
  9. Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.
  10. Patients with hypercoaguable conditions or risk of venous thrombosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280305

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Contact: Mark Weiser, MD 972-52-666-6575

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Sheba Medical Center
Ramat Gan, Israel, 52621
Contact: Mark Weiser, MD    972-52-666-6575   
Principal Investigator: Mark Weiser, MD         
Clinica de Psihiatrie, Arad
Arad, Romania
Contact: Delia Podea, MD    0722 583 757   
Principal Investigator: Delia Podea, MD         
Spitalul de Psihiatrie Botosani
Botosani, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucuresti, Romania
Contact: Dan Prelipceanu, MD    0722 300 227   
Principal Investigator: Dan Prelipceanu, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucuresti, Romania
Contact: Gabriela Marian, MD    0723 569 620   
Principal Investigator: Gabriela Marian, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucuresti, Romania
Contact: Maria Ladea, MD    0724 371 042   
Principal Investigator: Maria Ladea, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucuresti, Romania
Contact: Dorina-Valerica Sima, MD    0723 859 570   
Principal Investigator: Dorina-Valerica Sima, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucuresti, Romania
Contact: Maria-Silvia Trandafir, MD    0724 275 572   
Principal Investigator: Maria-Silvia Trandafir, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucuresti, Romania
Contact: Ana-Liana Giurgiuca, MD    0722 378 967   
Principal Investigator: Ana-Liana Giurgiuca, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucuresti, Romania
Contact: Valentin Matei, MD    0723 640 918   
Principal Investigator: Valentin Matei, MD         
Sp. Jud. "Prof. Dr.O. Fodor"
Cluj-Napoca, Romania
Contact: Mircea-Alexandru Birt, MD    0721 012 220   
Principal Investigator: Mircea-Alexandru Birt, MD         
Spitalul Clinic Judetean de Urgenta Cluj
Cluj, Romania
Contact: Ioana-Valentina Miclutia, MD    0722 796 067   
Principal Investigator: Ioana-Valentina Miclutia, MD         
Spitalul Clinic de Psihiatrie Socola, Iasi
Iasi, Romania
Contact: Serban Turliuc, MD    0745 203 002   
Principal Investigator: Serban Turliuc, MD         
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Mark Weiser, MD Sheba Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mark Weiser MD, Sheba Medical Center Identifier: NCT01280305    
Other Study ID Numbers: SHEBA-10-8287-MW-SHEBA
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: January 20, 2011
Last Verified: January 2011
Keywords provided by Sheba Medical Center:
schizoaffective disorder
Additional relevant MeSH terms:
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Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Raloxifene Hydrochloride
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents