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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201310083210N5
Enrollment
59
Registered
2015-12-02
Start date
2015-01-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia. Schizophrenia

Interventions

Intervention 1: 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. Intervention 2: Patients will recieve placebo in control group.
Treatment - Drugs
Placebo
Patients will receive memantine (once daily), in dosing titration as follows: week 1, 5mg/day
weeks 3-8, 20 mg/day, in addition to continuing tretment with antipsychotics for 8 weeks.
Patients will recieve placebo in control group.

Sponsors

Faculty of pharmacy, Shahid Beheshti University of Medical Scienses
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
PANSS score. Timepoint: At baseline, at the end of first and third month of the study. Method of measurement: Questionair.;Clinical evaluation. Timepoint: At baseline, at the end of first and third month of the study. Method of measurement: Questionair.

Secondary

MeasureTime frame
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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamide Abbaspour

Faculty of pharmacy, Shahid Beheshti University of Medical Sciencses

dr.abbaspour1@yahoo.com+98 11 4203 1035

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026