Myoinositol for the Treatment of Ovarian and Psychiatric Disorder in Polycystic Ovary Syndrome (PCOS) Patients
Recruitment status was: Recruiting
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
Dietary Supplement: Inositol
Dietary Supplement: Placebo
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Myoinositol for the Treatment of Ovarian and Psychiatric Disorder in PCOS Patients.|
- Hamilton Rating Scale for depression
- Hamilton Anxiety Scale
- Health assessment Questionnaire
- Short form of Mc Gill Pain Questionnaire
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: Inositol||Dietary Supplement: Inositol|
|Placebo Comparator: Placebo||Dietary Supplement: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246310
|Contact: Vittorio Unfer, MD||+39 firstname.lastname@example.org|
|Contact: Gianfranco Carlomagno, PhDemail@example.com|
|Rome, Italy, Rome|
|Contact: Vittorio Unfer, MD firstname.lastname@example.org|
|Contact: Gianfranco Carlomagno, PhD email@example.com|
|Principal Investigator: Vittorio Unfer, MD|
|Principal Investigator: Gianfranco Carlomagno, PhD|
|Principal Investigator:||Vittorio Unfer, MD||AGUNCO Obstetrics and Gynecology Centre|
|Principal Investigator:||Buffo Silvia, MD||Centro Clinico Colle Cesarano Tivoli Rome Italy|