DepressionPhase 4NCT06707012
Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
A Phase 4 study testing Metformin Hydrochloride in people with Depression, run by Fazaia Ruth Pfau Medical College at 2 sites in Pakistan.
Trial summary
To evaluate the efficacy of metformin as an adjunct therapy in improving depressive symptoms and metabolic markers in newly diagnosed obese depressed patients on standard antidepressant therapy. investigator will compare between Two groups 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Depression
- What is being tested?
- Metformin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Oct 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Age >18 to <45 years
- Gender: Both genders (Male and Female)
- BMI >25
- Diagnosis: Newly diagnose cases of depression (mild to severe)
- HBA1C: Less than 5.7% (non-diabetic range)
Who cannot join
- Existing diabetes
- Acute illnesses like acute kidney injury, recent history of myocardial infarction, acute liver injury
- Intellectual disabilities or inability to understand due to any reason
- Presence of Psychiatric disorders other than depression
- Chronic kidney disease (eGFR < 45 mL/min/1.73 m²).
- Use of any psychotropic medication within the past 6 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Fazaia Rurh Pfau Medical College
Karachi, Sindh, 75120
Masood Ahmed, MBBS,PHD, 03002922361, principal.frpmc@mail.au.edu.pk
Asgher Mehdi, MBBS, 03008228284, drasgharmehdi@gmail.com
- Recruiting
Fazaia Ruth Pfau Medical College
Karachi, Sindh, 75120
sadia khan, MBBS, 0331395046, sadiakhansk30@gmail.com
Asghar Mehdi, MBBS,PHD, 03008228284, drasgharmehdi@gmail.com
About this study
To evaluate the efficacy of metformin as an adjunct therapy in improving depressive symptoms and metabolic markers in newly diagnosed obese depressed patients on standard antidepressant therapy.
investigator will compare between Two groups
- metformin group 2 placebo group Primary outcome measure will be the improvement in depressive symptoms, indicating by a reduction in Hamilton Depression Rating Scale (HAM-D) scores. Secondary outcome measures will include the assessment of oxidative stress markers, specifically by measuring the increase in enzymatic activity of superoxide dismutase, catalase, and glutathione peroxidase Investigators hypothesize that the addition of metformin to standard antidepressant treatment will result in a significant reduction in symptoms of depression among newly diagnosed obese individuals.
Read the detailed description
This is a comparative clinical study with randomized groups. Participants will be allocated to either the metformin group or the placebo group in conjunction with standard antidepressant therapy. Randomization will be achieved using computer generated numbers in 1:1 ratio.
Metformin Group: Starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines.
Placebo Group: Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression.
Study will take place at psychiatric Out Patient Department of Fazaia Ruth Pfau Medical College and Hospital Karachi Pakistan
Investigators will recruit participants from the psychiatric outpatient department of PAF Hospital diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for at least 2 weeks and having obesity. depression is assessed with help of Hamilton Depression Scale (HAM-D). Participants whose score is above 8 and will meet the inclusion criteria will be added in study.
Informed consent:
Participants who meets the criteria will be asked for written informed consent form and explain in detail about the study
Base Line Data Collection After taking informed consent, detailed history, physical examination, HbA1c and serum creatinine will be measured. Participants whose HbA1c results is below 5.7% and creatinine clearance is above 30% will be selected in the study. Investigators will assess HbA1c, serum creatinine levels at every 12 weeks' interval. Serum levels of antioxidant enzymes (superoxide dismutase, catalase, glutathione peroxidase) will measured in participants by using biochemical assays at baseline and at the end of the study.
Follow up visits Participants will be followed up six times throughout the study duration. 1st follow up visit will occur at 4th week to evaluate the response to treatment by using Hamilton depression rating scale for depression, as according to Maudsley guidelines initial response to treatment should be assessed within 4 weeks. Next follow ups will take place at every 6th week till 36 weeks to assess improvement in depression and changes in BMI.
- Conditions
- Depression
- Being tested
- Metformin Hydrochloride
- Keywords
- Depression, oxidative stress, antidepressants, obesity
- Medical subject headings
- Depression, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
Also called GLUCOPHAGE
Participants will be divided in 2 groups
1 group will receive metformin and 2nd group will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | We will prescribe metformin with starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines. Receives: Drug: Metformin Hydrochloride |
| placebo group | Placebo comparator | Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression Receives: Drug: Metformin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease scoring of Hamilton depression rating scale
Primary outcome measure will be the improvement in depressive symptoms, indicating by a change in Hamilton Depression Rating Scale (HAM-D) scores. Decrease in the score will be considered as indicator of improvement in depression.
0-7: Normal (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23 and above: Very severe depression Investigators will compare the change in both groups.
Measured: 18 months
Secondary outcomes (1)
elevation in oxidative enzymes level (superoxide dismutase,catalase,glutathione peroxidase
Secondary outcome measures will include the change in oxidative stress markers, specifically by measuring the enzymatic activity of superoxide dismutase, catalase, and glutathione peroxidase. Increase in levels of enzymes will be considered as indicator of improvement of depression.
investigators will compare the change in both groups.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Oct 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Design This is a comparative clinical study with randomized groups. Participants will be allocated to either the metformin group or the placebo group in conjunction with standard antidepressant therapy. Randomization will be achieved using computer generated numbers in 1:1 ratio. Metformin Group: Starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines. Placebo Group: Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression Setting: At psychiatric Out Patient Department of Fazaia Ruth Pfau Medical College and Hospital Karachi Pakistan Study Duration: 18 months
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fazaia Ruth Pfau Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadia khan, Fazaia Ruth Pfau Medical College
- Investigators
- sadia khan, MBBS, Principal investigator, Fazaia Ruth Pfau Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707012
- Sponsor's protocol ID
- frpmc.edu.pk@sadiakhan12345678
- Other IDs
- FMC, University
- Status last verified
- Sep 2025
- First submitted
- 22 Nov 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared if required by authority
Publications
Guo M, Mi J, Jiang QM, Xu JM, Tang YY, Tian G, Wang B. Metformin may produce antidepressant effects through improvement of cognitive function among depressed patients with diabetes mellitus. Clin Exp Pharmacol Physiol. 2014 Sep;41(9):650-6. doi: 10.1111/1440-1681.12265.
PubMed 24862430Farooq S, Khan T, Zaheer S, Shafique K. Prevalence of anxiety and depressive symptoms and their association with multimorbidity and demographic factors: a community-based, cross-sectional survey in Karachi, Pakistan. BMJ Open. 2019 Nov 19;9(11):e029315. doi: 10.1136/bmjopen-2019-029315.
PubMed 31748286Heiskanen TH, Niskanen LK, Hintikka JJ, Koivumaa-Honkanen HT, Honkalampi KM, Haatainen KM, Viinamaki HT. Metabolic syndrome and depression: a cross-sectional analysis. J Clin Psychiatry. 2006 Sep;67(9):1422-7. doi: 10.4088/jcp.v67n0913.
PubMed 17017829Lang UE, Beglinger C, Schweinfurth N, Walter M, Borgwardt S. Nutritional aspects of depression. Cell Physiol Biochem. 2015;37(3):1029-43. doi: 10.1159/000430229. Epub 2015 Sep 25.
PubMed 26402520Luppino FS, de Wit LM, Bouvy PF, Stijnen T, Cuijpers P, Penninx BW, Zitman FG. Overweight, obesity, and depression: a systematic review and meta-analysis of longitudinal studies. Arch Gen Psychiatry. 2010 Mar;67(3):220-9. doi: 10.1001/archgenpsychiatry.2010.2.
PubMed 20194822Lee A, Morley JE. Metformin decreases food consumption and induces weight loss in subjects with obesity with type II non-insulin-dependent diabetes. Obes Res. 1998 Jan;6(1):47-53. doi: 10.1002/j.1550-8528.1998.tb00314.x.
PubMed 9526970Seifarth C, Schehler B, Schneider HJ. Effectiveness of metformin on weight loss in non-diabetic individuals with obesity. Exp Clin Endocrinol Diabetes. 2013 Jan;121(1):27-31. doi: 10.1055/s-0032-1327734. Epub 2012 Nov 12.
PubMed 23147210AlHussain F, AlRuthia Y, Al-Mandeel H, Bellahwal A, Alharbi F, Almogbel Y, Awwad O, Dala'een R, Alharbi FA. Metformin Improves the Depression Symptoms of Women with Polycystic Ovary Syndrome in a Lifestyle Modification Program. Patient Prefer Adherence. 2020 Apr 15;14:737-746. doi: 10.2147/PPA.S244273. eCollection 2020.
PubMed 32346286Calkin CV, Chengappa KNR, Cairns K, Cookey J, Gannon J, Alda M, O'Donovan C, Reardon C, Sanches M, Ruzickova M. Treating Insulin Resistance With Metformin as a Strategy to Improve Clinical Outcomes in Treatment-Resistant Bipolar Depression (the TRIO-BD Study): A Randomized, Quadruple-Masked, Placebo-Controlled Clinical Trial. J Clin Psychiatry. 2022 Feb 1;83(2):21m14022. doi: 10.4088/JCP.21m14022.
PubMed 35120288Jitca G, Gall Z, Jitca CM, But MG, Majai E. Drug Repurposing of Metformin for the Treatment of Haloperidol-Related Behavior Disorders and Oxidative Stress: A Preliminary Study. Pharmaceutics. 2024 Mar 15;16(3):403. doi: 10.3390/pharmaceutics16030403.
PubMed 38543297
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
- ClinicalTrials.gov ID
- NCT06707012
- Acronym / sponsor ID
- frpmc.edu.pk@sadiakhan12345678
- Conditions
- Depression
- Keywords
- Depression, oxidative stress, antidepressants, obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fazaia Ruth Pfau Medical CollegeUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of metformin as an adjunct therapy in improving depressive symptoms and metabolic markers in newly diagnosed obese depressed patients on standard antidepressant therapy.
investigator will compare between Two groups
- metformin group 2 placebo group Primary outcome measure will be the improvement in depressive symptoms, indicating by a reduction in Hamilton Depression Rating Scale (HAM-D) scores. Secondary outcome measures will include the assessment of oxidative stress markers, specifically by measuring the increase in enzymatic activity of superoxide dismutase, catalase, and glutathione peroxidase Investigators hypothesize that the addition of metformin to standard antidepressant treatment will result in a significant reduction in symptoms of depression among newly diagnosed obese individuals.
Detailed description
This is a comparative clinical study with randomized groups. Participants will be allocated to either the metformin group or the placebo group in conjunction with standard antidepressant therapy. Randomization will be achieved using computer generated numbers in 1:1 ratio.
Metformin Group: Starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines.
Placebo Group: Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression.
Study will take place at psychiatric Out Patient Department of Fazaia Ruth Pfau Medical College and Hospital Karachi Pakistan
Investigators will recruit participants from the psychiatric outpatient department of PAF Hospital diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for at least 2 weeks and having obesity. depression is assessed with help of Hamilton Depression Scale (HAM-D). Participants whose score is above 8 and will meet the inclusion criteria will be added in study.
Informed consent:
Participants who meets the criteria will be asked for written informed consent form and explain in detail about the study
Base Line Data Collection After taking informed consent, detailed history, physical examination, HbA1c and serum creatinine will be measured. Participants whose HbA1c results is below 5.7% and creatinine clearance is above 30% will be selected in the study. Investigators will assess HbA1c, serum creatinine levels at every 12 weeks' interval. Serum levels of antioxidant enzymes (superoxide dismutase, catalase, glutathione peroxidase) will measured in participants by using biochemical assays at baseline and at the end of the study.
Follow up visits Participants will be followed up six times throughout the study duration. 1st follow up visit will occur at 4th week to evaluate the response to treatment by using Hamilton depression rating scale for depression, as according to Maudsley guidelines initial response to treatment should be assessed within 4 weeks. Next follow ups will take place at every 6th week till 36 weeks to assess improvement in depression and changes in BMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study Design This is a comparative clinical study with randomized groups. Participants will be allocated to either the metformin group or the placebo group in conjunction with standard antidepressant therapy. Randomization will be achieved using computer generated numbers in 1:1 ratio. Metformin Group: Starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines. Placebo Group: Identical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression Setting: At psychiatric Out Patient Department of Fazaia Ruth Pfau Medical College and Hospital Karachi Pakistan Study Duration: 18 months
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Metformin HydrochlorideWe will prescribe metformin with starting dose of 500 mg metformin once daily, titrated up to 2000 mg/day based on tolerance along with standard treatment of depression according to Maudsley guidelines. |
| placebo group | Placebo comparator | Drug: Metformin HydrochlorideIdentical placebo tablets, following the same titration schedule as the metformin group along with standard treatment of depression |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Age >18 to <45 years
Key exclusion criteria (6 listed)
- Existing diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin HydrochlorideAlso: GLUCOPHAGEParticipants will be divided in 2 groups 1 group will receive metformin and 2nd group will receive placebo | Drug | Experimental, placebo group |
Primary outcome
Decrease scoring of Hamilton depression rating scale
Time frame: 18 months
Primary outcome measure will be the improvement in depressive symptoms, indicating by a change in Hamilton Depression Rating Scale (HAM-D) scores. Decrease in the score will be considered as indicator of improvement in depression. 0-7: Normal (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23 and above: Very severe depression Investigators will compare the change in both groups.
1 secondary outcome
elevation in oxidative enzymes level (superoxide dismutase,catalase,glutathione peroxidase
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 24862430Guo M, Mi J, Jiang QM, Xu JM, Tang YY, Tian G, Wang B. Metformin may produce antidepressant effects through improvement of cognitive function among depressed patients with diabetes mellitus. Clin Exp Pharmacol Physiol. 2014 Sep;41(9):650-6. doi: 10.1111/1440-1681.12265.
- Results publication: PubMed 31748286Farooq S, Khan T, Zaheer S, Shafique K. Prevalence of anxiety and depressive symptoms and their association with multimorbidity and demographic factors: a community-based, cross-sectional survey in Karachi, Pakistan. BMJ Open. 2019 Nov 19;9(11):e029315. doi: 10.1136/bmjopen-2019-029315.
- Results publication: PubMed 17017829Heiskanen TH, Niskanen LK, Hintikka JJ, Koivumaa-Honkanen HT, Honkalampi KM, Haatainen KM, Viinamaki HT. Metabolic syndrome and depression: a cross-sectional analysis. J Clin Psychiatry. 2006 Sep;67(9):1422-7. doi: 10.4088/jcp.v67n0913.
- Results publication: PubMed 26402520Lang UE, Beglinger C, Schweinfurth N, Walter M, Borgwardt S. Nutritional aspects of depression. Cell Physiol Biochem. 2015;37(3):1029-43. doi: 10.1159/000430229. Epub 2015 Sep 25.
- Results publication: PubMed 20194822Luppino FS, de Wit LM, Bouvy PF, Stijnen T, Cuijpers P, Penninx BW, Zitman FG. Overweight, obesity, and depression: a systematic review and meta-analysis of longitudinal studies. Arch Gen Psychiatry. 2010 Mar;67(3):220-9. doi: 10.1001/archgenpsychiatry.2010.2.
- Results publication: PubMed 9526970Lee A, Morley JE. Metformin decreases food consumption and induces weight loss in subjects with obesity with type II non-insulin-dependent diabetes. Obes Res. 1998 Jan;6(1):47-53. doi: 10.1002/j.1550-8528.1998.tb00314.x.
- Results publication: PubMed 23147210Seifarth C, Schehler B, Schneider HJ. Effectiveness of metformin on weight loss in non-diabetic individuals with obesity. Exp Clin Endocrinol Diabetes. 2013 Jan;121(1):27-31. doi: 10.1055/s-0032-1327734. Epub 2012 Nov 12.
- Results publication: PubMed 32346286AlHussain F, AlRuthia Y, Al-Mandeel H, Bellahwal A, Alharbi F, Almogbel Y, Awwad O, Dala'een R, Alharbi FA. Metformin Improves the Depression Symptoms of Women with Polycystic Ovary Syndrome in a Lifestyle Modification Program. Patient Prefer Adherence. 2020 Apr 15;14:737-746. doi: 10.2147/PPA.S244273. eCollection 2020.
- Results publication: PubMed 35120288Calkin CV, Chengappa KNR, Cairns K, Cookey J, Gannon J, Alda M, O'Donovan C, Reardon C, Sanches M, Ruzickova M. Treating Insulin Resistance With Metformin as a Strategy to Improve Clinical Outcomes in Treatment-Resistant Bipolar Depression (the TRIO-BD Study): A Randomized, Quadruple-Masked, Placebo-Controlled Clinical Trial. J Clin Psychiatry. 2022 Feb 1;83(2):21m14022. doi: 10.4088/JCP.21m14022.
- Results publication: PubMed 38543297Jitca G, Gall Z, Jitca CM, But MG, Majai E. Drug Repurposing of Metformin for the Treatment of Haloperidol-Related Behavior Disorders and Oxidative Stress: A Preliminary Study. Pharmaceutics. 2024 Mar 15;16(3):403. doi: 10.3390/pharmaceutics16030403.
- Individual participant dataSharing planned: No. It will be shared if required by authority
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
sadia khan, MBBS principal investigator
Fazaia Ruth Pfau Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin Hydrochloride in people with Depression, run by Fazaia Ruth Pfau Medical College at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadia khan, MBBS (0331359046 ext. 314, sadiakhansk30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease scoring of Hamilton depression rating scale (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707012, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.