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Study of the effect of Memantine on negative symptoms and inflammatory biomarkers (IL6, TNFa CRP) in patients with schizophrenia or schizoaffective disorders

Protocol summary

Summary
Schizophrenia is compromised of several debilitating symptoms. Antipsychotics offer an effective treatment for positive symptoms, while the negative sign and cognitive deficits are usually treatment-resistant. It was suggested that glutamate dysregulation may be involved in the neuropathology of schizophrenia, mainly through NMDA dysfunction. We hypothesized that addition of memantine, a weak non- selective NMDA receptor antagonist approve for dementia, to antipsychotics would improve the clinical status of un-remitted schizophrenia patient, notably the negative sign and cognitive deficits. in this double- blind, placebo controlled study, participants (59 patient ) were assigned to receive placebo or memantine (once daily), in dosing titration as follows: week 1, 5mg/day; week 2, 10 mg/day; weeks 3-8, 20 mg/day, in addition to continuing tretment with antipsychotics for 8 weeks. The primary efficacy measures was the total score on positive and negative symptom scale (PANSS) and secondry outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201310083210N5
Registration date: 2015-12-02, 1394/09/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences, Faculity of Pharmacy
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Memantine on negative symptoms and inflammatory biomarkers (IL6, TNFa CRP) in patients with schizophrenia or schizoaffective disorders
Public title
Study of the effect of Memantine on negative symptoms and inflammatory biomarkers (IL6, TNFa CRP) in patients with schizophrenia or schizoaffective disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 18-65 years old; patients that base on DSM V criteria has diagnosis of schizophrenia or schizoaffective disorder; patients who stable on medication four weeks prior to baseline and has not planned medication change. Exclusion criteria: subject that organic brain disease or neurological diagnosis (including neurological disorder or an active seizure); subjects who will meet the criteria for DSM-V diagnosis of alcohol or substance dependence within the last six month; any change of psychotropic medication within the previous four weeks.
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 59
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Street address
Vali-asr ave., Niayesh highway
City
Tehran
Postal code
Approval date
2015-07-26, 1394/05/04
Ethics committee reference number
SBMU2.REC.1394.62

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
PANSS score
Timepoint
At baseline, at the end of first and third month of the study
Method of measurement
Questionair

2

Description
Clinical evaluation
Timepoint
At baseline, at the end of first and third month of the study
Method of measurement
Questionair

Secondary outcomes

1

Description
Assessment of inflammatory biomarkers (IL6, TNF, CRP)
Timepoint
At baseline, at the end of first and third month of the study
Method of measurement
ELISA

2

Description
Assessment of inflammatory biomarkers (IL6, TNF, CRP)
Timepoint
At baseline, at the end of first and third month of the study
Method of measurement
ELISA

Intervention groups

1

Description
Patients will receive memantine (once daily), in dosing titration as follows: week 1, 5mg/day; week 2, 10 mg/day; weeks 3-8, 20 mg/day, in addition to continuing tretment with antipsychotics for 8 weeks.
Category
Treatment - Drugs

2

Description
Patients will recieve placebo in control group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maria Tavakoli Ardekani
Street address
Velenjak street, Shaheed Chamran highway
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of pharmacy, Shahid Beheshti University of Medical Scienses
Full name of responsible person
Dr. Maria Tavakoli Ardakani
Street address
Vali-asr ave., Niayesh high way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of pharmacy, Shahid Beheshti University of Medical Scienses
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of pharmacy, Shahid Beheshti University of Medical Sciencses
Full name of responsible person
Hamide Abbaspour
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Valiasr Ave., Niayesh highway
City
Tehran
Postal code
Phone
+98 11 4203 1035
Fax
Email
dr.abbaspour1@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of pharmacy, Shahid Beheshti University of Medical Scienses
Full name of responsible person
Dr Maria Tavakoli Ardakani
Position
Associate professor, Academic member / PhD
Other areas of specialty/work
Street address
Valiasr Ave., Niayesh highway
City
Tehran
Postal code
Phone
+98 21 8820 0085
Fax
Email
mariatavakoli@yahoo.com; mariatavakoli@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciencses
Full name of responsible person
Dr. Hamideh Abbaspour
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Valiasr Ave., Niayesh highway
City
Tehran
Postal code
Phone
+98 11 4203 1035
Fax
Email
dr.abbaspour1@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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