Status:
COMPLETED
The Antidiabetic Metformin as a Novel Adjunct to Antidepressants in Major Depressive Disorder Patients
Lead Sponsor:
Sadat City University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of our study was to test whether the combined administration of the SSRI fluoxetine and metformin, a drug improving metabolic profile and therefore potentially able to mimic the influence of s...
Detailed Description
Selective Serotonin Reuptake Inhibitors (SSRIs) represent the standard treatment for Major Depressive Disorder (MDD). However, their efficacy is variable and incomplete. In order to explain, at least ...
Eligibility Criteria
Inclusion
- Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
- Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.
Exclusion
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with substance dependence or abuse
- Patients with concurrent active medical condition
- Patients with history of seizures
- Patients with history of receiving Electroconvulsive therapy (ECT)
- Patients with diabetes and other inflammatory disorders
- Patients with allergy or contraindications to the used medications
- Patients with finally pregnant or lactating females
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04088448
Start Date
January 1 2017
End Date
June 1 2020
Last Update
June 16 2020
Active Locations (1)
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1
Faculty of Medicine
Tanta, Egypt