Health Condition 1: N958- Other specified menopausal and perimenopausal disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females who are currently physically well and between 40 and 65 years of age 2. Current DSM-IV diagnosis of depression disorder 3. Able to give informed consent 4. Perimenopausal as determined by symptom profile on the Stages of Reproductive Aging Workshop and gonadal hormonal profile
Exclusion criteria
Exclusion criteria: 1. Known abnormalities in the hypothalamic-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal Pap smear results in the previous 2 years. 2. Patients with H/O any significant unstable medical illness such as epilepsy and diabetes, hypertension or known active cardiac, renal or liver disease;malignancy or the presence of illness causing immobilisation. 3. Patients receiving treatment for depression including antidepressant medications, electroconvulsive therapy (ECT) / Transcranial Magnetic Stimulation (TMS), formal psychotherapy or counselling, within the past 6 months. 4. Patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment. 5. Patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder. 6. Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meno D scoreTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| meno dTimepoint: 8 weeks | — |
Countries
India