ClinicalTrials.gg
Status unknownNCT01280305RAL-S-01Updated Jan 20, 2011

Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder

A Phase 3 interventional study of raloxifene and placebo in Schizophrenia and Schizoaffective Disorder, sponsored by Sheba Medical Center. Status unknown at 13 sites in 2 countries. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-01-20.

Sponsored by Sheba Medical Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder

Keywords

  • schizophrenia
  • schizoaffective disorder
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In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 677 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    raloxifene

    Drug: raloxifene

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • raloxifene 60 mg bid

  • Drugplacebo

    Placebo bid

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What researchers measure

Primary outcomes

  1. PANSS total score at the end of the trial.

    PANSS will be assesed at weeks 5, 8 and end of study.

    Time frame: 3 times

Secondary outcomes

  1. PANSS,CGI-S, CGI-I, BACS and rates of drop outs before the end of the trial.

    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.

    Time frame: PANSS 3 times, CGI-S and CGI-I 5 times and BACS 2 times

07

Study locations

13 sites
  • Sheba Medical Center
    Ramat Gan, 52621, Israel
  • Clinica de Psihiatrie, Arad
    Arad, Romania
    • Delia Podea, MD · Contact · deliapodea@gmail.com · 0722 583 757
    • Delia Podea, MD · Principal investigator
  • Spitalul de Psihiatrie Botosani
    Botoșani, Romania
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
    Bucharest, Romania
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
    Bucharest, Romania
    • Gabriela Marian, MD · Contact · gabi.marian@yahoo.com · 0723 569 620
    • Gabriela Marian, MD · Principal investigator
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
    Bucharest, Romania
    • Maria Ladea, MD · Contact · marialadea@gmail.com · 0724 371 042
    • Maria Ladea, MD · Principal investigator
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
    Bucharest, Romania
    • Dorina-Valerica Sima, MD · Contact · dorinasima@yahoo.com · 0723 859 570
    • Dorina-Valerica Sima, MD · Principal investigator
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
    Bucharest, Romania
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
    Bucharest, Romania
    • Ana-Liana Giurgiuca, MD · Contact · giurgiuca_liana@yahoo.com · 0722 378 967
    • Ana-Liana Giurgiuca, MD · Principal investigator
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
    Bucharest, Romania
    • Valentin Matei, MD · Contact · petcu_camelia@yahoo.com · 0723 640 918
    • Valentin Matei, MD · Principal investigator
  • Sp. Jud. "Prof. Dr.O. Fodor"
    Cluj-Napoca, Romania
    • Mircea-Alexandru Birt, MD · Contact · mirceabirt@yahoo.com · 0721 012 220
    • Mircea-Alexandru Birt, MD · Principal investigator
  • Spitalul Clinic Judetean de Urgenta Cluj
    Cluj-Napoca, Romania
    • Ioana-Valentina Miclutia, MD · Contact · ioanamiclu@yahoo.com · 0722 796 067
    • Ioana-Valentina Miclutia, MD · Principal investigator
  • Spitalul Clinic de Psihiatrie Socola, Iasi
    Iași, Romania
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References and documents

Publications

  • Weiser M, Levi L, Burshtein S, Hagin M, Matei VP, Podea D, Miclutia I, Tiugan A, Pacala B, Grecu IG, Noy A, Zamora D, Davis JM. Raloxifene Plus Antipsychotics Versus Placebo Plus Antipsychotics in Severely Ill Decompensated Postmenopausal Women With Schizophrenia or Schizoaffective Disorder: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e758-e765. doi: 10.4088/JCP.15m10498. PubMed 28541645 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01280305
First posted
Jan 20, 2011
Start date
Mar 2011
Primary completion
Dec 2012 (estimated)
Completion
Mar 2013 (estimated)
Last update
Jan 20, 2011

Study contacts

Mark Weiser, MD
Contact
mweiser@netvision.net.il
972-52-666-6575
Mark Weiser, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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