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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centro Clinico Colle Cesarano Tivoli Rome Italy
Information provided by:
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01246310
First received: November 19, 2010
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Depression
PCOS
Dietary Supplement: Inositol
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Primary Outcome Measures:
  • Hamilton Rating Scale for depression
  • Hamilton Anxiety Scale
  • Health assessment Questionnaire
  • Short form of Mc Gill Pain Questionnaire

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inositol Dietary Supplement: Inositol
Placebo Comparator: Placebo Dietary Supplement: Placebo

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246310

Contacts
Contact: Vittorio Unfer, MD +39 0640500835 vunfer@gmail.com
Contact: Gianfranco Carlomagno, PhD gianfranco.carlomagno@gmail.com

Locations
Italy
Agunco Recruiting
Rome, Italy, Rome
Contact: Vittorio Unfer, MD       vunfer@gmail.com   
Contact: Gianfranco Carlomagno, PhD       gianfranco.carlomagno@gmail.com   
Principal Investigator: Vittorio Unfer, MD         
Principal Investigator: Gianfranco Carlomagno, PhD         
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
  More Information

Publications:
Responsible Party: AGUNCO Obstetrics & Gynecology Center
ClinicalTrials.gov Identifier: NCT01246310     History of Changes
Other Study ID Numbers: agunco7/2010
Study First Received: November 19, 2010
Last Updated: June 23, 2011
Health Authority: Italy: National Institute of Health

Additional relevant MeSH terms:
Ovarian Cysts
Mental Disorders
Depression
Depressive Disorder
Polycystic Ovary Syndrome
Behavioral Symptoms
Mood Disorders
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014