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

NCT04088448 | Completed Phase 1 DMC

• 1 other identifier: 0056/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Effect on Hamilton Depression rating scale score (HAM-D score)

  The principal measure of the outcome was the 17-items HAM-D. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-13 suggest mild depression, 14-17 moderate depression and scores over 17 are indicative of severe depression. Remission is defined as HAM-D total score ≤ 7 (primary outcome). Treatment response is defined as ≥ 50% drop in the HAM-D total score.

  Baseline to week 12

Secondary Outcomes (4)

• TNF-α

  Baseline to week 12

• BDNF

  Baseline to week 12

• CRP

  Baseline to week 12

• IGF-1

  Baseline to week 12

Study Arms (2)

Control group

PLACEBO COMPARATOR

Fluoxetine 20 mg capsule once daily for 12 week plus placebo tablet once daily for 12 weeks

Drug: Placebo oral tablet

Metformin group

EXPERIMENTAL

Fluoxetine 20 mg capsule once daily for 12 week plus Metformin 1000 mg XR tablet once daily for 12 weeks

Drug: Metformin

Interventions

Placebo oral tablet DRUG

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

Control group

Metformin DRUG

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

Metformin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Medicine

Tanta, Egypt

Location

Related Publications (1)

• Abdallah MS, Mosalam EM, Zidan AA, Elattar KS, Zaki SA, Ramadan AN, Ebeid AM. The Antidiabetic Metformin as an Adjunct to Antidepressants in Patients with Major Depressive Disorder: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. Neurotherapeutics. 2020 Oct;17(4):1897-1906. doi: 10.1007/s13311-020-00878-7.

  PMID: 32500486 DERIVED

Related Links

• The Antidiabetic Metformin as an Adjunct to Antidepressants in Patients with Major Depressive Disorder: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Metformin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy, PhD.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: January 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)