Protocol summary
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Study aim
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Determining the effect of memantine on cognitive symptoms in patients with schizophrenia
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Design
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A clinical trial with a placebo group, with parallel groups, blind, randomized, double-blinded
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Settings and conduct
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This study, which is a randomized, double-blind clinical trial, was conducted on patients aged 50-18 years old with schizophrenia (according to DSM-IV criteria) admitted to Kargrinejad Kashan Psychiatric Hospital for at least 3 months of treatment of schizophrenia were taken.
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Participants/Inclusion and exclusion criteria
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Patients with schizophrenia according to DSM-IV criteria have a short mental state score of between 18 and 24.
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Intervention groups
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Patients received 3 to 4 mg anti-cholinergic antibiotics at a constant dose of 300 to 1000 mg of chlorpromazine (with the exception of clozapine) for 3 months and 3 to 8 mg of terrigenophylline. A group treated with memantine was given 5 mg daily for 3 months and received a dose of up to 20 mg daily. This dose was selected according to the effective dose for patients with dementia. The second group was treated with placebo, which was similar in flavor, color and mode, for 3 months. Both groups underwent the usual treatment for schizophrenia (a constant dose of 300-1000 mg of chlorpromazine (excluding clozapine) and a constant dose of anticholinergic drug equivalent to 4 to 8 mg tricyclichephenidyl).
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Main outcome variables
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Hamilton Depression Scale (HAM-D), Grade Severity of Positive and Negative Symptoms of Schizophrenia (PANSS), Adult Wechsler Memory Score (WAIS-III)
General information
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Reason for update
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Change the number of samples and start time
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190606043827N1
Registration date:
2020-02-08, 1398/11/19
Registration timing:
retrospective
Last update:
2020-04-23, 1399/02/04
Update count:
1
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Registration date
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2020-02-08, 1398/11/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-01, 1398/06/10
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Expected recruitment end date
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2019-12-25, 1398/10/04
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of Memantine on cognitive impairment in schizophrenic patients
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Public title
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Memantine effect on patients with schizophrenia
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Schizophrenia according to DSM-IV criteria
Age 18 to 50 years
Receiving common drugs for schizophrenia for at least 3 months before the start of the study (Patients within 3 months of the previous 3 month antipsychotic with a constant dose of 300 to 1000 mg of chlorpromazine (except for clozapine) and a fixed dose of anticholinergic drug of 4 to 8 mg TG Phenidyl)
Mental Status Mini Test Score (MMSE) Between 18 and 24
Exclusion criteria:
Dependence and drug addiction
smoking
History of trauma to the head
History of seizure
Severe liver and kidney function disorders
Severe neurological disorders
Depression
Receiving drugs that affect cognitive symptoms
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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All patients aged 18-50 years with schizophrenia (according to DSM-IV criteria) admitted to Kargarinejad Psychiatric Hospital in Kashan who had been undergoing routine schizophrenia for at least 3 months were randomly selected. Sampling was done randomly until the sample size was completed and information was collected through interviews, observation, and questionnaires. Patients were randomly divided into two groups: A and B. Randomization was done by using a random number table.
Regarding concealment, a random sequence was given to a person in this method and sampling was performed at one or more centers simultaneously. Based on the order of the participants' entry into the study, the researcher communicates with the relevant center and asks about the random assignment of the participant to a specific group. Communication methods include phone, SMS, fax, email, and more.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study was a double-blind clinical trial. Patients and staff are unaware of the drug and placebo dose.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-26, 1398/06/04
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Ethics committee reference number
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IR.kaums.mednt.rec.1398.064
Health conditions studied
1
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Description of health condition studied
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Schizophrenia
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ICD-10 code
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F20
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ICD-10 code description
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Schizophrenia
Primary outcomes
1
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Description
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Adult Wechsler Memory Test Score
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Timepoint
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Measurement of mean Wechsler Adult Memory Test score from baseline, 6th week and 12th week after drug and placebo study.
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Method of measurement
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Adult Wechsler memory test
2
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Description
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Grade Severity of Positive and Negative Symptoms of Schizophrenia
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Timepoint
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Measure the mean score of severity of positive and negative symptoms of schizophrenia from baseline, 6th week and 12th week after drug and placebo study.
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Method of measurement
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Questionnaire on the severity of positive and negative symptoms of schizophrenia
3
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Description
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Hamilton Depression Scale Score
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Timepoint
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Measurement of mean Hamilton Depression Rating Scale from baseline, 6th and 12th week after drug and placebo study.
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Method of measurement
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Hamilton Depression Scale Questionnaire
Intervention groups
1
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Description
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Intervention group: The group was treated with memantine 5 mg (Made in Iran and Tolid daru factory)daily for 3 months and dosed at a maximum of 20 mg daily. This dose was selected according to the effective dose for patients with dementia.
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Category
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Treatment - Drugs
2
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Description
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Control group: The second group was treated with placebo, which was similar in flavor, color and mode, for 3 months.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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In this study, some of the data, such as medical information, can be shared.
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When the data will become available and for how long
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Start the access period 1 month after printing results
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To whom data/document is available
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scholars and students
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Under which criteria data/document could be used
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All scholars and students are required to apply ethical principles to the use of paper data.
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From where data/document is obtainable
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To the author responsible
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What processes are involved for a request to access data/document
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Request by email
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Comments
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