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

Sponsor
AGUNCO Obstetrics and Gynecology Centre (Other)
Overall Status
Terminated
CT.gov ID
NCT01246310
Collaborator
Centro Clinico Colle Cesarano Tivoli Rome Italy (Other)
24
1
2
135
0.2

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Inositol
  • Dietary Supplement: Placebo
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Myoinositol for the Treatment of Ovarian and Psychiatric Disorder in PCOS Patients.
Actual Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Inositol

Dietary Supplement: Inositol

Placebo Comparator: Placebo

Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures

  1. Hamilton Rating Scale for depression []

  2. Hamilton Anxiety Scale []

  3. Health assessment Questionnaire []

  4. Short form of Mc Gill Pain Questionnaire []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Agunco Rome Italy Rome

Sponsors and Collaborators

  • AGUNCO Obstetrics and Gynecology Centre
  • Centro Clinico Colle Cesarano Tivoli Rome Italy

Investigators

  • Principal Investigator: Vittorio Unfer, MD, AGUNCO Obstetrics and Gynecology Centre
  • Principal Investigator: Buffo Silvia, MD, Centro Clinico Colle Cesarano Tivoli Rome Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01246310
Other Study ID Numbers:
  • agunco7/2010
First Posted:
Nov 23, 2010
Last Update Posted:
Mar 3, 2022
Last Verified:
Feb 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2022