DepressionNCT01246310
Myoinositol for the Treatment of Ovarian and Psychiatric Disorder in Polycystic Ovary Syndrome (PCOS) Patients
A study testing Inositol in people with Depression and PCOS, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
Polycystic ovary syndrome (PCOS) is one of the most common reproductive disorders affecting 5-10% of women of reproductive age. Beside impairments on reproductive functions (oligomenorrhea/amenorrhea), it also affects metabolism (insulin resistance, type 2 diabetes mellitus and cardiovascular risk) and psychology… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Depression, PCOS
- What is being tested?
- Inositol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed of PCOS according to Rotterdam 2003 criteria
Who cannot join
- BMI >30
- Pharmacological treatment in the last 3 moths
- Use of contraceptive pill
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myoinositol for the Treatment of Ovarian and Psychiatric Disorder in PCOS Patients.
Polycystic ovary syndrome (PCOS) is one of the most common reproductive disorders affecting 5-10% of women of reproductive age. Beside impairments on reproductive functions (oligomenorrhea/amenorrhea), it also affects metabolism (insulin resistance, type 2 diabetes mellitus and cardiovascular risk) and psychology (increased anxiety, depression and eating disorders). Recently, several studies have shown that there is an increased risk of mood disorders in women with PCOS, with major depression and bipolar disorder as the most frequent diagnosis.
Myo-inositol is classified as a member of the vitamin B complex and it works as a second messenger system of several neurotransmitter receptors; furthermore, inositol, when administrated at pharmacological doses, crosses the blood-brain barrier.
Read more
Studies from the 90s showed that inositol, alone or in combination with other antidepressant drugs (mainly serotonin reuptake inhibitors), is able to induce improvement of the Hamilton depression rating Scale.
Recently, inositol has been proposed as treatment to improve clinical, metabolic and endocrinal status in PCOS patients. Administration of myo-inositol to PCOs patients resulted in several beneficial effects, such as decrease of circulating insulin and serum total testosterone as well as a restored ovulation.
In this proposed study, the investigators aim to evaluate in a double blind randomized trial whether inositol alone has beneficial effects on mental health disorders associated with PCOs. In particular, 60 women in reproductive age that will be diagnosed of PCOs, according to Rotterdam 2003 criteria, will be recruited and randomly assigned to the inositol or placebo group. Both groups will go through ultrasonic evaluation of the ovaries and serum hormonal levels (FSH, LH, testosterone, estradiol and insulin) will be evaluated. Furthermore, with the help of psychiatrics, patients will be interviewed in order to test the presence of any mental health disorders using validated tests such as: Hamilton Anxiety Scale (HAM-A), Hamilton Rating Scale for Depression (HAM-D), Health Assessment Questionnaire (HAQ), Short Form of Mc Gill Pain Questionnaire (SF-MPQ).
Women assigned to the inositol group will receive 12g of inositol during the day in three different administrations for a period of 4weeks.
At the end of treatment period patients will be interviewed by psychiatrics and will go through ultrasonic evaluation of the ovaries and hormonal levels will be tested
- Conditions
- Depression, PCOS
- Being tested
- Inositol, Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InositolDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Inositol | Experimental | Not described Receives: Dietary Supplement: Inositol |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for depression
Hamilton Anxiety Scale
Health assessment Questionnaire
Short form of Mc Gill Pain Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2022
- Study completionFeb 2022
Why it stopped: The number of patients enrolled was insufficient to match the calculated sample size and to carry out statistical analyses
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Clinico Colle Cesarano Tivoli Rome Italy
- Responsible party
- Sponsor
- Investigators
- Vittorio Unfer, MD, Principal investigator, AGUNCO Obstetrics and Gynecology CentreBuffo Silvia, MD, Principal investigator, Centro Clinico Colle Cesarano Tivoli Rome Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246310
- Sponsor's protocol ID
- agunco7/2010
- Status last verified
- Feb 2022
- First submitted
- 19 Nov 2010
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Costantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10.
PubMed 19499845Levine J, Barak Y, Gonzalves M, Szor H, Elizur A, Kofman O, Belmaker RH. Double-blind, controlled trial of inositol treatment of depression. Am J Psychiatry. 1995 May;152(5):792-4. doi: 10.1176/ajp.152.5.792.
PubMed 7726322Kerchner A, Lester W, Stuart SP, Dokras A. Risk of depression and other mental health disorders in women with polycystic ovary syndrome: a longitudinal study. Fertil Steril. 2009 Jan;91(1):207-12. doi: 10.1016/j.fertnstert.2007.11.022. Epub 2008 Feb 4.
PubMed 18249398Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
PubMed 19800728Teede H, Deeks A, Moran L. Polycystic ovary syndrome: a complex condition with psychological, reproductive and metabolic manifestations that impacts on health across the lifespan. BMC Med. 2010 Jun 30;8:41. doi: 10.1186/1741-7015-8-41.
PubMed 20591140Baptiste CG, Battista MC, Trottier A, Baillargeon JP. Insulin and hyperandrogenism in women with polycystic ovary syndrome. J Steroid Biochem Mol Biol. 2010 Oct;122(1-3):42-52. doi: 10.1016/j.jsbmb.2009.12.010. Epub 2009 Dec 28.
PubMed 20036327
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myoinositol for the Treatment of Ovarian and Psychiatric Disorder in PCOS Patients.
- ClinicalTrials.gov ID
- NCT01246310
- Acronym / sponsor ID
- agunco7/2010
- Conditions
- Depression, PCOS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of patients enrolled was insufficient to match the calculated sample size and to carry out statistical analyses
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Collaborators
- Centro Clinico Colle Cesarano Tivoli Rome Italy
- Study start
- Nov 2010 (actual)
- Primary completion
- Feb 2022 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 23 Nov 2010 (estimated)
- 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.
Polycystic ovary syndrome (PCOS) is one of the most common reproductive disorders affecting 5-10% of women of reproductive age. Beside impairments on reproductive functions (oligomenorrhea/amenorrhea), it also affects metabolism (insulin resistance, type 2 diabetes mellitus and cardiovascular risk) and psychology (increased anxiety, depression and eating disorders). Recently, several studies have shown that there is an increased risk of mood disorders in women with PCOS, with major depression and bipolar disorder as the most frequent diagnosis.
Myo-inositol is classified as a member of the vitamin B complex and it works as a second messenger system of several neurotransmitter receptors; furthermore, inositol, when administrated at pharmacological doses, crosses the blood-brain barrier.
Studies from the 90s showed that inositol, alone or in combination with other antidepressant drugs (mainly serotonin reuptake inhibitors), is able to induce improvement of the Hamilton depression rating Scale.
Recently, inositol has been proposed as treatment to improve clinical, metabolic and endocrinal status in PCOS patients. Administration of myo-inositol to PCOs patients resulted in several beneficial effects, such as decrease of circulating insulin and serum total testosterone as well as a restored ovulation.
In this proposed study, the investigators aim to evaluate in a double blind randomized trial whether inositol alone has beneficial effects on mental health disorders associated with PCOs. In particular, 60 women in reproductive age that will be diagnosed of PCOs, according to Rotterdam 2003 criteria, will be recruited and randomly assigned to the inositol or placebo group. Both groups will go through ultrasonic evaluation of the ovaries and serum hormonal levels (FSH, LH, testosterone, estradiol and insulin) will be evaluated. Furthermore, with the help of psychiatrics, patients will be interviewed in order to test the presence of any mental health disorders using validated tests such as: Hamilton Anxiety Scale (HAM-A), Hamilton Rating Scale for Depression (HAM-D), Health Assessment Questionnaire (HAQ), Short Form of Mc Gill Pain Questionnaire (SF-MPQ).
Women assigned to the inositol group will receive 12g of inositol during the day in three different administrations for a period of 4weeks.
At the end of treatment period patients will be interviewed by psychiatrics and will go through ultrasonic evaluation of the ovaries and hormonal levels will be tested
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inositol | Experimental | Dietary Supplement: Inositol |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women diagnosed of PCOS according to Rotterdam 2003 criteria
Key exclusion criteria (3 listed)
- BMI >30
- Pharmacological treatment in the last 3 moths
- Use of contraceptive pill
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 |
|---|---|---|
| Inositol | Dietary supplement | Inositol |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Hamilton Rating Scale for depression
Hamilton Anxiety Scale
Health assessment Questionnaire
Short form of Mc Gill Pain Questionnaire
Results and safety
The study was stopped early (reason given: The number of patients enrolled was insufficient to match the calculated sample size and to carry out statistical analyses). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Background: PubMed 19499845Costantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10.
- Background: PubMed 7726322Levine J, Barak Y, Gonzalves M, Szor H, Elizur A, Kofman O, Belmaker RH. Double-blind, controlled trial of inositol treatment of depression. Am J Psychiatry. 1995 May;152(5):792-4. doi: 10.1176/ajp.152.5.792.
- Background: PubMed 18249398Kerchner A, Lester W, Stuart SP, Dokras A. Risk of depression and other mental health disorders in women with polycystic ovary syndrome: a longitudinal study. Fertil Steril. 2009 Jan;91(1):207-12. doi: 10.1016/j.fertnstert.2007.11.022. Epub 2008 Feb 4.
- Background: PubMed 19800728Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
- Background: PubMed 20591140Teede H, Deeks A, Moran L. Polycystic ovary syndrome: a complex condition with psychological, reproductive and metabolic manifestations that impacts on health across the lifespan. BMC Med. 2010 Jun 30;8:41. doi: 10.1186/1741-7015-8-41.
- Background: PubMed 20036327Baptiste CG, Battista MC, Trottier A, Baillargeon JP. Insulin and hyperandrogenism in women with polycystic ovary syndrome. J Steroid Biochem Mol Biol. 2010 Oct;122(1-3):42-52. doi: 10.1016/j.jsbmb.2009.12.010. Epub 2009 Dec 28.
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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. This study is not recruiting at the moment.
Vittorio Unfer, MD principal investigator
AGUNCO Obstetrics and Gynecology Centre
Buffo Silvia, MD principal investigator
Centro Clinico Colle Cesarano Tivoli Rome Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inositol in people with Depression and PCOS, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
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 1 inclusion and 3 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 3 Mar 2022. 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 Italy. 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.
Are results available for this study?
The study was stopped early (reason given: The number of patients enrolled was insufficient to match the calculated sample size and to carry out statistical analyses). Results are not available in the source record.
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?
Hamilton Rating Scale for depression. The study lists 4 primary outcomes in all. 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 NCT01246310, which also lists 6 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 3 Mar 2022.