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Efficacy of rivastigmin in the treatment of major depressive disorder

Phase 2
Conditions
Major Depressive Disorder.
Moderate depressive episode
Registration Number
IRCT2017020132236N4
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
20
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Memory. Timepoint: At the baseline and on the third month. Method of measurement: Wechsler Memory Scale.
Secondary Outcome Measures
NameTimeMethod
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.
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