Myoinositol for the Treatment of Ovarian and Psychiatric Disorder in Polycystic Ovary Syndrome (PCOS) Patients

Depression Clinical Trial

Official title:

Myoinositol for the Treatment of Ovarian and Psychiatric Disorder in PCOS Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01246310
• Other study ID #: agunco7/2010
• Status: Terminated
• Phase: N/A
• Start date: November 2010
• Est. completion date: February 2022

Study information

• Verified date: February 2022
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women diagnosed of PCOS according to Rotterdam 2003 criteria

Exclusion Criteria:

• BMI >30
• Pharmacological treatment in the last 3 moths
• Use of contraceptive pill

Related Conditions & MeSH terms

• Depression
• Mental Disorders
• PCOS
• Problem Behavior

Intervention

Dietary Supplement:
• Inositol

• Placebo

Locations

Country	Name	City	State
Italy	Agunco	Rome

Sponsors (2)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre	Centro Clinico Colle Cesarano Tivoli Rome Italy

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Baptiste 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. Review. — View Citation

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. — View Citation

Kerchner 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. — View Citation

Levine 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. — View Citation

Papaleo 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. Review. — View Citation

Teede 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for depression
Primary	Hamilton Anxiety Scale
Primary	Health assessment Questionnaire
Primary	Short form of Mc Gill Pain Questionnaire