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To study the effectiveness of the drug tibolone in post menopausal depression

Effectiveness of tibolone in post menopausal depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030776
Enrollment
60
Registered
2021-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F32- Major depressive disorder, singleepisode

Interventions

Intervention1: role of tibolone in postmenopausal depression: EFFECTIVENESS OF TIBOLONE IN POST MENOPAUSAL DEPRESSION in dose of 2.5 mg/day oral given daily for 12 weeks Intervention2: Study will comp

Sponsors

Department of psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Females who have currently achieved natural menopause • Physiologic menopause with amenorrhea for at least 1 year • Able to give informed consent • First-onset or relapse depression during menopause • Patients of depression diagnosed acc to DSM 5 criteria

Exclusion criteria

Exclusion criteria: 1. Patients with any history of thyroid dysfunction, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal Pap smear results . 2. Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; or the presence of illness causing immobilisation. 3.Patients with psychotic symptoms or past history of severe mental illness. 4. 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 5. Smoking cigarettes or other nicotine products 6. Illicit drug use 7. More than 3 standard drinks per day

Design outcomes

Primary

MeasureTime frame
1. To study effectiveness of tibolone in post menopausal depression and anxiety by HAM D, HAM ATimepoint: baseline, 2 weeks , 4 weeks , 8 weeks , 12 weeks

Secondary

MeasureTime frame
2. To assess change in quality of life of post menopausal women with tibolone. By WHO QOL scale 4. To assess sexual functioning among Postmenopausal women and change in sexual functioning with tibolone. By ASEX, FSFI Timepoint: baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks

Countries

India

Contacts

Public ContactNamita Sharma

Government Medical college patiala

profheadpsy@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026