PCOSPhase 4MINDDNCT03380091
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial
A Phase 4 study testing Metformin and Vitamin D in people with PCOS and Depression, run by University of California, San Francisco at 1 site in United States.
Trial summary
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS, Depression, Vitamin D Deficiency
- What is being tested?
- Metformin and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 1 Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)
- Vitamin D insufficiency (serum Vitamin D <30 ng/mL)
- Insulin resistance
- Mild or greater severity of depression by Beck Depression Inventory-II
Who cannot join
- Current metformin use
- Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D insufficiency
- Insulin-dependent diabetes mellitus
- Pregnancy or breastfeeding
- Untreated hypothyroidism
- Current active substance abuse
- Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Center for Reproductive Health
San Francisco, California, 94158
About this study
Official title: Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
Read the detailed description
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.
- Conditions
- PCOS, Depression, Vitamin D Deficiency, Insulin Resistance
- Keywords
- PCOS, Depression, Vitamin D, Insulin Resistance, Anxiety, Quality of life, Mood disorders
- Medical subject headings
- Depression, Vitamin D Deficiency, Insulin Resistance, Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage, Glucophage XR, Fortamet, Glumetza
Oral medication daily
Vitamin DDrug
Also called Cholecalciferol
Oral medication daily
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin 1000 mg PO bid Receives: Drug: Metformin |
| Vitamin D (Cholecalciferol) | Experimental | Cholecalciferol 5,000 IU PO daily Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline & 12 weeks
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: Baseline week & week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start12 Dec 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Huddleston, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380091
- Sponsor's protocol ID
- 17-22550
- Acronym
- MINDD
- Status last verified
- Jan 2021
- First submitted
- 15 Dec 2017
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial
- ClinicalTrials.gov ID
- NCT03380091
- Acronym / sponsor ID
- MINDD / 17-22550
- Conditions
- PCOS, Depression, Vitamin D Deficiency, Insulin Resistance
- Keywords
- PCOS, Depression, Vitamin D, Insulin Resistance, Anxiety, Quality of life, Mood disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 9 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin 1000 mg PO bid |
| Vitamin D (Cholecalciferol) | Experimental | Drug: Vitamin DCholecalciferol 5,000 IU PO daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)
- Vitamin D insufficiency (serum Vitamin D <30 ng/mL)
- Insulin resistance
- Mild or greater severity of depression by Beck Depression Inventory-II
Key exclusion criteria (8 listed)
- Current metformin use
- Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D insufficiency
- Insulin-dependent diabetes mellitus
- Pregnancy or breastfeeding
- Untreated hypothyroidism
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 |
|---|---|---|
| MetforminAlso: Glucophage, Glucophage XR, Fortamet, GlumetzaOral medication daily | Drug | Metformin |
| Vitamin DAlso: CholecalciferolOral medication daily | Drug | Vitamin D (Cholecalciferol) |
Primary outcome
Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks
Time frame: Baseline & 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
3 secondary outcomes
Changes From Baseline Week in Insulin Resistance Score at Week 12.
Time frame: Baseline week & week 12
Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks
Time frame: Baseline week & Week 12
Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.
Time frame: Baseline week & week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for PCOS
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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. This study is not recruiting at the moment.
Heather Huddleston, MD principal investigator
University of California, San Francisco
1 site 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 and Vitamin D in people with PCOS and Depression, run by University of California, San Francisco at 1 site in United States.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks (time frame: Baseline & 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.