A Phase 4 interventional study of Metformin and Vitamin D in PCOS, Depression and Vitamin D Deficiency, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
Among 10 studies testing metformin in Depression — 3 open to participants now, 3 under way, none of them phase 3. Metformin · Depression.
Among the 10 studies testing metformin in Depression, this one is the 9th largest by enrollment, is the only one that started in 2017, is one of 6 in phase 4, and was the 5th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
Browse Depression studies →3 of the 10 studies testing metformin in Depression are open now, in 2 countries. Recruiting first, the newest first:
Riphah International University · Sites in Pakistan
Healthy volunteers
Fazaia Ruth Pfau Medical College · Sites in Pakistan
Ages 18–45
Beni-Suef University · Sites in Egypt
Ages 45–60
By country, each count listing its studies:
Metformin: first FDA approval 1995 (GLUCOPHAGE), first EMA approval 2003. What it is approved for, and how studies give it, is on its page →
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years to 45 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 5 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Median enrollment 71 across the 10 interventional studies. Of the 5 that completed or were terminated, 4 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 10 most frequent:
University of California, San Francisco is the lead sponsor of 2,170 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
64 studies in Depression by University of California, San Francisco: 8 open now, 10 under way, none of them phase 3. Of 53 finished, 14 (26%) have results posted.
Among the 64 studies in Depression by University of California, San Francisco, this one is the 59th largest by enrollment of the 61 interventional ones that give a count, is one of 3 that started in 2017, is one of 4 in phase 4, and was the 32nd registered.
University of California, San Francisco’s Depression studies by the year they started, since 2003.
1 of the studies testing metformin in Depression that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07654179Riphah International UniversityMetformin as Adjunct Therapy in Depression-obesity Comorbidity: Clinical and Genetic Evaluation | 2027-06-11 |
Add it to your calendar (.ics) → With an account.
Among the 10 studies testing metformin in Depression, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among University of California, San Francisco’s 64 in Depression:
This tab as a report to print or save as PDF → With an account.
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
This is a single center, open-label, randomized, pilot clinical trial. Women with polycystic ovary syndrome and depressed mood, who are insulin resistant and vitamin D insufficient are eligible. Subjects are randomly assigned to one of two interventions: Vitamin D versus metformin. Subjects are followed with questionnaires and a final wrap-up clinic visit with a physician. The study duration is 12 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Metformin 1000 mg PO bid
Drug: Metformin
Cholecalciferol 5,000 IU PO daily
Drug: Vitamin D
Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks
BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score
Time frame: Baseline & 12 weeks
Changes From Baseline Week in Insulin Resistance Score at Week 12.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnostics. HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance.
Time frame: Baseline week & week 12
Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks
STAI-S is a validated self-reported instrument of 20 questions. Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms. Change = Week 12 total score - Baseline week score
Time frame: Baseline week & Week 12
Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.
Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Changes in values from baseline week to week 12 will be calculated. Reference ranges: optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient \<20ng/mL
Time frame: Baseline week & week 12
| Milestone | Vitamin D (Cholecalciferol) | Metformin |
|---|---|---|
| Started | 3 | 2 |
| Began arm treatment | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score
| score on a scale | Vitamin D (Cholecalciferol) | Metformin |
|---|---|---|
| Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks | -8 ± 0 | 7 ± 0 |
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnostics. HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance.
| units on a scale | Vitamin D (Cholecalciferol) | Metformin |
|---|---|---|
| Changes From Baseline Week in Insulin Resistance Score at Week 12. | 0.81 ± 0 | -1.2 ± 0 |
STAI-S is a validated self-reported instrument of 20 questions. Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms. Change = Week 12 total score - Baseline week score
| score on a scale | Metformin | Vitamin D (Cholecalciferol) |
|---|---|---|
| Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks | 0 ± 0 | 10 ± 0 |
Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Changes in values from baseline week to week 12 will be calculated. Reference ranges: optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient \<20ng/mL
| mg/dL | Vitamin D (Cholecalciferol) | Metformin |
|---|---|---|
| Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12. | 11 ± 0 | -5 ± 0 |
Collected over Study activity participation window of 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D (Cholecalciferol) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Metformin | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
Although 3 participants were assigned to Vitamin D, one dropped out just after enrollment and arm assigment and another dropped out after completing baseline time point measures, thus only one participant in the Vitamin D arm had data available for outcome measures analysis. Although 2 participants were assigned to Metformin, one dropped out just after enrollment and arm assignment, thus only one participant in the Metformin arm had data available for outcome measures analysis.
| Age, Categorical(Participants) | Vitamin D (Cholecalciferol) | Metformin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Vitamin D (Cholecalciferol) | Metformin | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Vitamin D (Cholecalciferol) | Metformin | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Vitamin D (Cholecalciferol) | Metformin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vitamin D (Cholecalciferol) | Metformin | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
| Fasting Insulin(μIU/mL) | Vitamin D (Cholecalciferol) | Metformin | Total |
|---|---|---|---|
| Mean | 14.2 ± 4.6 | 32 ± 0 | 20.13 ± 9.19 |
| Fasting Glucose(mg/dL) | Vitamin D (Cholecalciferol) | Metformin | Total |
|---|---|---|---|
| Mean | 90.5 ± 3.5 | 83 ± 0 | 88 ± 4.54 |
| Fasting Insulin Resistance(units on a scale) | Vitamin D (Cholecalciferol) | Metformin | Total |
|---|---|---|---|
| Mean | 3.12 ± 0.92 | 6.6 ± 0 | 4.28 ± 1.80 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Sep 2019, 20 months.
Results were first posted in Feb 2021, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Metformin · Vitamin D
University of California, San Francisco →