Memantine effect in the treatment of residual symptoms in patients with schizophrenia
- Conditions
- Schizophrenia.F20.5
- Registration Number
- IRCT2017013032236N2
- Lead Sponsor
- Vice chancellor for research, Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
1- Male or female are recruited from in-patient units in yahyaneghad hospital located in Babol in the north of Iran
2-18–65 years at the time of screening
3-With a diagnosis of schizophrenia(paranoid, disorganized, catatonic, or undifferentiated type)or schizoaffective disorder, based on the Structured Clinical Interview for DSM-V and they are suffering from the disease for more than 2 years with residual symptomatology despite antipsychotic treatment
4- All patients are on antipsychotics for at least 1 year and a stable dose for at least 2 month are included in the trial and the antipsychotics dose remain unchanged during the trial.
5-Mood stabilizers (lithium and divalproex) and antidepressants (only the selective serotonine reuptake inhibitors (SSRIs) venlafaxine, and mirtazapine) were permitted as part of antipsychotic pharmacotherapy. Dose of these drugs must be stable for at least 2 month remain unchanged during the trial.
Exclusions criteria:
1-Acute relapse (As acute relapse was defined an impending decompensation based on a PANSS score of =4 (moderately) on the subscore items of hostility and uncooperativeness and/or a =20% increase in the PANSS total score.
2-Psychiatric comorbidity(primary or secondary diagnosis of bipolar I disorder, either manic or mixed episode, as defined by DSM-V)
3-History of substance dependence (including alcohol, but excluding nicotine) as defined by DSM-V and relapse within the past 6 months, or substance abuse within the 3 months preceding the trial or positive urine test for illicit drugs
4-Electroconvulsive therapy during the 6 past months
5-Suicidality(active suicide or homicide intent, or a suicide or homicide attempt in the preceding 6 months)
6-Mental retardation
7-Pregnant or at risk of pregnancy
8-Cognitive disorders such as dementia, delirium, or amnesia, traumatic brain injury
9-Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
10-Hypersensitivity to memantine
11-Previous treatment with memantine in the past year
12-History of neuroleptic malignant syndrome
13-Patients under treatment cholinesterase inhibitors, N-methyl D-aspartate (NMDA) receptor antagonists
14- Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of psychiatric symptoms assesment. Timepoint: Baseline and weeks 3, 6 and 8. Method of measurement: Positive and Negative Syndrome Scale (PANSS).
- Secondary Outcome Measures
Name Time Method Depressed mood assessment. Timepoint: Baseline and weeks 3, 6 and 8. Method of measurement: Calgary Depression Scale for Schizophrenia.;Severity and type of obsessive compulsive symptoms assessment. Timepoint: Baseline and weeks 3, 6 and 8. Method of measurement: Yale–Brown Obsessive Compulsive Scale.;Clinical Global Impression of Improvement (CGI-S). Timepoint: Baseline and weeks 3, 6 and 8. Method of measurement: Clinical Global Impression of Improvement (CGI-S).;Clinical Global Impression of Improvement (CGI-I). Timepoint: Baseline and weeks 3, 6 and 8. Method of measurement: Clinical Global Impression of Improvement (CGI-I).;Nigella sativa induced akathisia assessment. Timepoint: Weekly. Method of measurement: Barnes Akathisia Scale.;Nigella sativa induced Movement disorder assessment. Timepoint: Weekly. Method of measurement: Abnormal Involuntary Movement Scale.