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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
raloxifene
placebo
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba Medical Center
  • Clinica de Psihiatrie, Arad
  • Spitalul de Psihiatrie Botosani
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
  • Sp. Jud. "Prof. Dr.O. Fodor"
  • Spitalul Clinic Judetean de Urgenta Cluj
  • Spitalul Clinic de Psihiatrie Socola, Iasi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

raloxifene

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 19, 2011
Last Updated
January 19, 2011
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01280305
Brief Title
Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder
Acronym
RAL-S-01
Official Title
A Randomized Trial Administering Raloxifene vs Placebo as add-on to Antipsychotics in Post Menopausal Patients With Schizophrenia or Schizoaffective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
schizophrenia, schizoaffective disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
raloxifene
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
raloxifene
Intervention Description
raloxifene 60 mg bid
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo bid
Primary Outcome Measure Information:
Title
PANSS total score at the end of the trial.
Description
PANSS will be assesed at weeks 5, 8 and end of study.
Time Frame
3 times
Secondary Outcome Measure Information:
Title
PANSS,CGI-S, CGI-I, BACS and rates of drop outs before the end of the trial.
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). 45-65 years old Willing and able to provide informed consent, after the nature of the study has been fully explained. 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. 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. 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. Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission. Exclusion Criteria: Unwilling or unable, in the opinion of the Investigator, to comply with study instructions Women of child bearing potential. Women who have amenorrhea due to causes other than natural or surgical menopause i.e. eating disorders or exercise Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning. Patients treated with cholestyramine, warfarin or concurrent systemic estrogen therapy Likely allergy or sensitivity to raloxifene. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others. 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. Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma. Patients with hypercoaguable conditions or risk of venous thrombosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Weiser, MD
Phone
972-52-666-6575
Email
mweiser@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Weiser, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Weiser, MD
Phone
972-52-666-6575
Email
mweiser@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Mark Weiser, MD
Facility Name
Clinica de Psihiatrie, Arad
City
Arad
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delia Podea, MD
Phone
0722 583 757
Email
deliapodea@gmail.com
First Name & Middle Initial & Last Name & Degree
Delia Podea, MD
Facility Name
Spitalul de Psihiatrie Botosani
City
Botosani
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
City
Bucuresti
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Prelipceanu, MD
Phone
0722 300 227
Email
prelipceanudan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dan Prelipceanu, MD
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
City
Bucuresti
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Marian, MD
Phone
0723 569 620
Email
gabi.marian@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gabriela Marian, MD
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
City
Bucuresti
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Ladea, MD
Phone
0724 371 042
Email
marialadea@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Ladea, MD
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
City
Bucuresti
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorina-Valerica Sima, MD
Phone
0723 859 570
Email
dorinasima@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dorina-Valerica Sima, MD
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
City
Bucuresti
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria-Silvia Trandafir, MD
Phone
0724 275 572
Email
silviatrandafir2004@yahoo.com
First Name & Middle Initial & Last Name & Degree
Maria-Silvia Trandafir, MD
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
City
Bucuresti
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana-Liana Giurgiuca, MD
Phone
0722 378 967
Email
giurgiuca_liana@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ana-Liana Giurgiuca, MD
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
City
Bucuresti
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentin Matei, MD
Phone
0723 640 918
Email
petcu_camelia@yahoo.com
First Name & Middle Initial & Last Name & Degree
Valentin Matei, MD
Facility Name
Sp. Jud. "Prof. Dr.O. Fodor"
City
Cluj-Napoca
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mircea-Alexandru Birt, MD
Phone
0721 012 220
Email
mirceabirt@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mircea-Alexandru Birt, MD
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj
City
Cluj
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioana-Valentina Miclutia, MD
Phone
0722 796 067
Email
ioanamiclu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ioana-Valentina Miclutia, MD
Facility Name
Spitalul Clinic de Psihiatrie Socola, Iasi
City
Iasi
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serban Turliuc, MD
Phone
0745 203 002
Email
serban_turliuc@yahoo.com
First Name & Middle Initial & Last Name & Degree
Serban Turliuc, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28541645
Citation
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.
Results Reference
derived

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Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder

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