Comparison of Venlafaxine and Sertraline Therapeutic Effects on Depression in Patients with Epilepsy

Phase 2

Conditions: Condition 1: Depressive Disorders. Condition 2: Epilepsy.
Mood disorder due to known physiological condition with depressive features
Epilepsy and recurrent seizures
F06.31

Registration Number: IRCT20210608051515N2

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 30

Inclusion Criteria

Definite Diagnosis of Epilepsy based on Clinical Findings and Neurologist View
Positive Evaluation of Depression based on NDDI-E Questionnaire
Clinical Diagnosis of Moderate to Severe Depression Using Hamilton Depression Scale

Exclusion Criteria

Suicide Attempt in Recent Year
Alcohol or Substance Abuse
History of a Complex Mood Disorder e.g. Bipolar Disorder
Other Accompanying Neurological Disease
Evidence of Hypersensitivity to SSRIs
Hypertension
Major Kidney or Liver Dysfunction
Active Hemorrhage
Pregnancy and Breast-feeding

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of depression in patients with epilepsy participating in the study according to the Hamilton scale. Timepoint: Depression severity at the beginning of the study (before the intervention), the third, eighth, and sixteenth weeks after the intervention is evaluated. Method of measurement: Hamilton depression clinical scale (HAM-D).

Secondary Outcome Measures

Name	Time	Method
umber of seizures that occur during the week (if any). Timepoint: At the beginning of the study (before the intervention) and then the third, eighth, and sixteenth week after the intervention. Method of measurement: Counting the number of seizures per week based on history.;Quality of Life in Epilepsy. Timepoint: Before initiating the therapy and after sixteen week of treatment. Method of measurement: Quality of Life in Epilepsy (31 Questions) Questionnaire.;Pharmacological side effects. Timepoint: In the first week and then the third and eighth after the intervention. Method of measurement: Based on the history and a prepared form of drug side effects.