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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01280305
First received: January 19, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: raloxifene
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • PANSS total score at the end of the trial. [ Time Frame: 3 times ] [ Designated as safety issue: No ]
    PANSS will be assesed at weeks 5, 8 and end of study.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: raloxifene Drug: raloxifene
raloxifene 60 mg bid
Placebo Comparator: Placebo Drug: placebo
Placebo bid

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

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280305

Contacts
Contact: Mark Weiser, MD 972-52-666-6575 mweiser@netvision.net.il

Locations
Israel
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52621
Contact: Mark Weiser, MD    972-52-666-6575    mweiser@netvision.net.il   
Principal Investigator: Mark Weiser, MD         
Romania
Clinica de Psihiatrie, Arad Not yet recruiting
Arad, Romania
Contact: Delia Podea, MD    0722 583 757    deliapodea@gmail.com   
Principal Investigator: Delia Podea, MD         
Spitalul de Psihiatrie Botosani Active, not recruiting
Botosani, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia" Not yet recruiting
Bucuresti, Romania
Contact: Maria-Silvia Trandafir, MD    0724 275 572    silviatrandafir2004@yahoo.com   
Principal Investigator: Maria-Silvia Trandafir, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia" Not yet recruiting
Bucuresti, Romania
Contact: Dan Prelipceanu, MD    0722 300 227    prelipceanudan@yahoo.com   
Principal Investigator: Dan Prelipceanu, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia" Not yet recruiting
Bucuresti, Romania
Contact: Maria Ladea, MD    0724 371 042    marialadea@gmail.com   
Principal Investigator: Maria Ladea, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia" Not yet recruiting
Bucuresti, Romania
Contact: Gabriela Marian, MD    0723 569 620    gabi.marian@yahoo.com   
Principal Investigator: Gabriela Marian, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia" Not yet recruiting
Bucuresti, Romania
Contact: Valentin Matei, MD    0723 640 918    petcu_camelia@yahoo.com   
Principal Investigator: Valentin Matei, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia" Not yet recruiting
Bucuresti, Romania
Contact: Dorina-Valerica Sima, MD    0723 859 570    dorinasima@yahoo.com   
Principal Investigator: Dorina-Valerica Sima, MD         
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia" Not yet recruiting
Bucuresti, Romania
Contact: Ana-Liana Giurgiuca, MD    0722 378 967    giurgiuca_liana@yahoo.com   
Principal Investigator: Ana-Liana Giurgiuca, MD         
Spitalul Clinic Judetean de Urgenta Cluj Not yet recruiting
Cluj, Romania
Contact: Ioana-Valentina Miclutia, MD    0722 796 067    ioanamiclu@yahoo.com   
Principal Investigator: Ioana-Valentina Miclutia, MD         
Sp. Jud. "Prof. Dr.O. Fodor" Not yet recruiting
Cluj-Napoca, Romania
Contact: Mircea-Alexandru Birt, MD    0721 012 220    mirceabirt@yahoo.com   
Principal Investigator: Mircea-Alexandru Birt, MD         
Spitalul Clinic de Psihiatrie Socola, Iasi Not yet recruiting
Iasi, Romania
Contact: Serban Turliuc, MD    0745 203 002    serban_turliuc@yahoo.com   
Principal Investigator: Serban Turliuc, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Mark Weiser, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Mark Weiser MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01280305     History of Changes
Other Study ID Numbers: SHEBA-10-8287-MW-SHEBA
Study First Received: January 19, 2011
Last Updated: January 19, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
schizophrenia
schizoaffective disorder

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Raloxifene
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014