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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was:  Recruiting
Centro Clinico Colle Cesarano Tivoli Rome Italy
Information provided by:
AGUNCO Obstetrics and Gynecology Centre Identifier:
First received: November 19, 2010
Last updated: June 23, 2011
Last verified: June 2011

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
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.

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


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01246310

Contact: Vittorio Unfer, MD +39 0640500835
Contact: Gianfranco Carlomagno, PhD

Agunco Recruiting
Rome, Italy, Rome
Contact: Vittorio Unfer, MD   
Contact: Gianfranco Carlomagno, PhD   
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
Principal Investigator: Vittorio Unfer, MD AGUNCO Obstetrics and Gynecology Centre
Principal Investigator: Buffo Silvia, MD Centro Clinico Colle Cesarano Tivoli Rome Italy
  More Information

Responsible Party: AGUNCO Obstetrics & Gynecology Center Identifier: NCT01246310     History of Changes
Other Study ID Numbers: agunco7/2010
Study First Received: November 19, 2010
Last Updated: June 23, 2011

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Mental Disorders
Problem Behavior
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Behavioral Symptoms
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on September 21, 2017