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The Antidiabetic Metformin as a Novel Adjunct to Antidepressants in Major Depressive Disorder Patients

NCT04088448 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-06-16

No results posted yet for this study

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 supportive living conditions on treatment outcome, results in an improved antidepressant efficacy compared with fluoxetine alone.

Conditions

Interventions

DRUG

Placebo oral tablet

Fluoxetine 20 mg capsule plus Placebo tablet administered once daily after food

DRUG

Metformin

Fluoxetine 20 mg capsule plus Metformin 1000 mg extended release tablet administered once daily after food

Sponsors & Collaborators

  • Sadat City University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-06-01
Completion
2020-06-01

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088448 on ClinicalTrials.gov