Effect of Bupropion in diabetes patients with mild depression

Efficacy and safety of Bupropion in Glycemic control and self-care Adherence in type 2 diabetes with mild depression: A randomised open-labelled crossover controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046411

Enrollment

Registered

2022-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Bupropion: An extended release preparation of Bupropion 150mg tablet will be given once daily for three months. Control Intervention1: Standard of care: Any modality of treatment as adv

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age of 30 – 70 years 2. Diagnosis of type 2 Diabetes Mellitus as per IDF criteria 3. Duration of T2 DM for 5 years or more 4. HbA1c between 6.5% and 12% 5. Having a score of 5-9 (mild) on Patient Health Questionnaire-9

Exclusion criteria

Exclusion criteria: 1. Type 1 Diabetes Mellitus 2. Patient who had any significant neurological disorders, or with any significant medical or surgical condition 3. History of traumatic brain injury 4. Patient having any co-morbid psychiatric disorder other than mild depression, or history of any psychiatric illness 5. Treatment with antipsychotic or antidepressant medications, benzodiazepines, dopaminergic medications, monoamine oxidase inhibitors, or amantadine within the last 4 weeks before study participation 6. Pregnant and lactating women 7. History of allergy/intolerance to Bupropion

Design outcomes

Primary

Measure	Time frame
1. To compare the effect of add on Bupropion versus standard of care on HbA1c in T2 DM patients with mild depression 2. To compare the effect of add on Bupropion versus standard of care on adherence to self-care activities in T2 DM patients with mild depression Timepoint: Baseline and after three months of treatment	—

Secondary

Measure	Time frame
To evaluate the effect on adverse events of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on autonomic function test of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on lipid profile parameters of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on quality of life of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on sexual satisfaction of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on urinary albumin-to-creatinine ratio(UACR) of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment	—

Measure

Time frame

To evaluate the effect on adverse events of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on autonomic function test of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on lipid profile parameters of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on quality of life of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on sexual satisfaction of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment;To evaluate the effect on urinary albumin-to-creatinine ratio(UACR) of add on Bupropion versus standard of care in T2 DM patients with mild depressionTimepoint: Baseline and after three months of treatment

—

Countries

India

Contacts

Public ContactMuhammad Aaqib Shamim

All India Institute of Medical Sciences, Jodhpur

ravindrashukla2@rediffmail.com8697190025

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026