Major Depressive Disorder. Moderate depressive episode
Conditions
Interventions
Intervention 1: The control group receive sertraline with placebo for three months. Intervention 2: Subjects in the intervention group receive rivastigmin with an initial dose of 1.5 mg/day from f
Placebo
Treatment - Drugs
The control group receive sertraline with placebo for three months.
Subjects in the intervention group receive rivastigmin with an initial dose of 1.5 mg/day from first to third days, which is increased to 3 mg/day on the fourth day and continue with the same dose
Sponsors
Vice chancellor for research, Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: All outpatients with Major Depressive Disorder based on DSM-IV-TR in the age range of 25-55 year old who refer to psychiatric clinic in Imam khomeini hospital clinic. Exclusions criteria: Psychiatric comorbidity(primary or secondary diagnosis of bipolar I disorder, either manic or mixed episode, as defined by DSM-V);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;Electroconvulsive therapy during the 6 past months;Suicidality(active suicide or homicide intent, or a suicide or homicide attempt in the preceding 6 months);Mental retardation;Pregnant or at risk of pregnancy; Cognitive disorders such as dementia, delirium, or amnesia, traumatic brain injury;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;Hypersensitivity to rivastigmin;Previous treatment with rivastigmin in the past year; History of neuroleptic malignant syndrome;Patients under treatment cholinesterase inhibitors, N-methyl D-aspartate (NMDA) receptor antagonists;Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Memory. Timepoint: At the baseline and on the third month. Method of measurement: Wechsler Memory Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression severity assessment. Timepoint: At the baseline and on the third month. Method of measurement: Hamilton Depression Rating Scale.;Rivastigmin side effects. Timepoint: Weekly. Method of measurement: With direct questions and observing main complications. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Narjes Hendouei
Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Outcome results
None listed