To determine the effect of Levetiracetam on cognitive function and quality of life in patients with schizophrenia
Design
40 schizophrenic patients were divided into two groups of intervention and control through block randomization.Randomized, double-blind, placebo-controlled, single-center, phase II trial.
Settings and conduct
The study was conducted at Clinic of Psychiatry of the University Hospital Ibn.e.Sina and Dr. Hejazi, Mashhad. patient was diagnosed with schizophrenia (excluding catatonic schizophrenia subgroups) aged 18-60 years are evaluated based on the inclusion and exclusion criteria (listed below) and only patients who meet these criteria are selected. as a double blind (the patient, elevator and physician a will be blind and the medication and placebo in envelopes A and B will be given by the nurse).
Participants/Inclusion and exclusion criteria
Inclusion criteria; Schizophrenia during partial recovery-Have a normal IQ. do not Be in the acute phase of schizophrenia. haven untreated with clozapine antipsychotic drug.
The patient do not take anticholinergic and benzodiazepine medications- Non-pregnant or breastfeeding (Pregnancy Detection Based on BHCG Pregnancy Test).-have not History of drug use in the past 6 months (except nicotine).
Exclusion criteria; Lack of consent for participation in the study
Serious medical illness
Intervention groups
Intervention group: Levetiracetam (LEV) group, after 2 weeks of antipsychotic treatment, 2-week baseline period at 250 mg LEV dose and increase to maximum LEV dose (500 mg twice daily), and 8-week period intervention will complete.In the placebo group, a placebo that looks similar to levetiracetam is used according to the same protocol.
Main outcome variables
cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N32
Registration date:2020-04-06, 1399/01/18
Registration timing:registered_while_recruiting
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of levetiracetam on cognitive symptoms in schizophrenic patients
Public title
Evaluation of efficacy of levetiracetam on cognitive symptoms in schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6-month to 10-year history of schizophrenia
Have a normal IQ
Do not be in the acute phase of schizophrenia.
The patient do not take anticholinergic and benzodiazepine medications
do not history of drug use in the past 6 months (except nicotine)
Do not be pregnant or breastfeeding (Pregnancy Detection Based on BHCG Pregnancy Test)
Exclusion criteria:
Lack of consent for participation in the study
Serious medical illness
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly divided into two groups using a random number table.
Individuals who receive the odd number enter the intervention group, and people with even numbers are placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be assigned to the treatment and control group with a random number table. The nurse will control the drug instruction. The treating physician will examine the patients and be unaware of the intervention. The trial runs in a double-blind manner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Qoreishi Building, Daneshgah Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2019-04-09, 1398/01/20
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.231
Health conditions studied
1
Description of health condition studied
schizophrenic
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
cognitive function
Timepoint
At baseline, weeks 4 and 8
Method of measurement
Wisconsin questionnaire, Stroop test
2
Description
Quality of Life
Timepoint
At baseline, weeks 4 and 8
Method of measurement
The Positive and Negative syndrome Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: levetiracetam (LEV) group, after 2 weeks of antipsychotic treatment, 2-week baseline period at 250 mg LEV dose and increase to maximum LEV dose (500 mg twice daily), and 8-week period intervention will complete.
Category
Treatment - Drugs
2
Description
Control group: placebo group, a placebo that looks similar to levetiracetam is used according to the same protocol.