An open label Randomized placebo-controlled trial of Individualized Homoeopathic Medicine Versus Placebo as an Add-On to Standard Treatment in Manic Episode-A Pilot study.

Title

An open label Randomized placebo-controlled trial of Individualized Homoeopathic Medicine Versus Placebo as an Add-On to Standard Treatment in Manic Episode-A Pilot study.

|Short title

Homoeopathy verse placebo as an Add-On Treatment in Manic Episodes.

|Study design

An open label Randomized placebo-controlled trial.

|Study duration

4 years 3 months (2 years enrollment + 2 years intervention + 3 months data analysis and compilation)

|Study centre

National Homoeopathy Research Institute in Mental Health

|Primary Objective

i) To compare the time span for bringing remission from baseline to end of manic symptoms as assessed by the YMRS.

|Secondary objectives

i) To assess changes in YMRS BPRS.

ii) To find out the improvement in functional impairments with

FAST (Functional Assessment Short Test) between the groups.

iii) Compare the relapse between the groups.

iv) To evaluate reduction of medicine and dosage of Standard

Treatment between the groups.

|Diagnosed by

The diagnosis will be based upon ICD-10 classification of Mental and Behavioural disorders Diagnostic Criteria for Research and it will be confirmed by psychiatrist.

|Number of subjects

A minimum sample of 30 cases is required in each group. Considering drop outs, 68 cases (34 in each group) may be enrolled.

|Inclusion criteria

1.Patients of both genders between 20-60 years of age diagnosed

with mania or manic episodes of Bipolar Affective Disorders

with or without psychotic symptoms.

|Exclusion criteria

1. Patients diagnosed with Bipolar II disorder.

2. Patients with anti-social personality disorder.

Mental and behavioural disorders due to psychoactive

Substance abuse.

4. Organic mental disorders such dementia, delirium.

5. The patients who are taking treatment for mania from any other

system of   medicines.

Patients who are having suicidal thoughts.

|Study product, dose, route, regimen

Individualized homoeopathic treatment, Placebo, Standard Treatment Care. Regimen as per the principles of Homoeopathy. Oral route. Minimum dose repetition will be done according to the condition. The both groups, standard treatment Care, dosage and repetition will solely be decided by the Consultant Psychiatrist

|Scales/ Questionnaire proposed to be used

Ø  YMRS (Young Mania Rating Scale).

Ø  BPRS (Brief Psychiatry Rating Scale).

Ø  FAST (Functional Assessment Short Test

|Statistical methodology

The time span taken for remission in both groups will be assessed and compared using Kaplan Meier estimates, Log Rank test and Cox Regression Analysis.

The changes in YMRS, BPRS and FAST will be compared using Mixed Repeated Measures ANOVA.

Chi Square test will be used to compare the no. of cases with relapse in both the groups.

Changes in dosage of Standard treatment will be compared using Independent sample t test.