Homeopathic treatment of geriatric depression

Phase 2/3

Recruiting

Conditions: Major depressive disorder, recurrent, unspecified,

Registration Number: CTRI/2017/03/008078

Lead Sponsor: MBHM College Hospital MHM College Hospital The CHM College Hospital

Brief Summary: Depressionis the most common mental disorder in community settings, and is a major causeof disability across the world. In 1990, it was the fourth commonest cause ofloss of disability adjusted life years in the world, and by 2020, it isprojected to become the second commonest cause. A range of therapeutic approachesare available, the most widely used, in developed countries, is antidepressant drugs.Still, there still remain flaws in the treatment of depression withantidepressants, in terms of efficacy, adverse effects, toxicity overdose, non-complianceto treatment and delayed onset of their therapeutic response. Use of homeopathyto treat psychiatric problems is widespread, and the need for more high qualitycontrolled trials has been identified. Meta-analyses and systematic reviewshave drawn mixed conclusions as to whether homeopathy is more effective thanplacebo in general medicine. Theauthors undertook a cross-sectional validation survey, followed by open,observational trial involving 60 patients suffering from geriatric depression inthe geriatric outpatient of Midnapore Homeopathic Medical College &Hospital (MHMC&H), Govt. of West Bengal, India from May 2015 to April 2016using Geriatric Depression Scale (GDS). After3 months of treatment, moderate to large effect size was observed and the questionnaire psychometrics appearedsatisfactory. Theauthors intend to undertake a multicenter placebo-controlled double-blindrandomized efficacy trial of individualized homeopathic treatment on minimum150 patients suffering from geriatric depression at Midnapore HomoeopathicMedical College and Hospital (MHMC&H), Mahesh Bhattacharyya HomoeopathicMedical College and Hospital (MBHMC&H); and The Calcutta HomoeopathicMedical College and Hospital (CHMC&H). We hypothesize that individualizedhomeopathic treatment may produce effect significantly different from placeboin treatment of geriatric depression. The outcome measures are Geriatricdepression score questionnaire and Quality of Life Scale score questionnaire,to be measured at baseline and after 3 months. Intervention is planned asadministering indicated homeopathic remedies in centesimal potencies orplacebo, indistinguishable from verum. The generated results will be analyzedin the end using appropriate statistical tests and the results will bepublished in scientific research journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 150

Inclusion Criteria

Aged 60-80 years, both sexes, and suffering from depression [Geriatric Depression Score: â‰¥ 5].

Exclusion Criteria

Patients who are too sick for consultation, unwilling to take part, unable to read, and not giving consent to join the study, diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting QoL, currently receiving standard psychiatric therapy (conventional medication), chronic alcoholism, drug abuse and/or dependence, self-reported immune-compromised state, and undergoing homeopathic treatment for any chronic disease within last 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
15-items short-form Geriatric Depression Score (translated Bengali version)	At baseline and after 3 months

Secondary Outcome Measures

Name	Time	Method
16-items Quality of Life Scale score (translated Bengali version)	At baseline and after 3 months

Trial Locations

Locations (3): Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
🇮🇳
Haora, WEST BENGAL, India
Midnapore Homeopathic Medical College and Hospital
🇮🇳
Medinipur, WEST BENGAL, India
The Calcutta Homoeopathic Medical College & Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
🇮🇳Haora, WEST BENGAL, India
Shubhamoy Ghosh
Principal investigator
9831034229
shubhamoy67@gmail.com