To study the effect of ACETYL-L-CARNITINE as supplementin Clozapine resistant Schizophrenia

Recruitment & Eligibility

Inclusion Criteria

INCLUSION CRITERIA

1. Patients (Male & Female) in the age group of 18 to 60 years.

2. Patients suffering from schizophrenia as per ICD-11.

3. Patients who fulfilled the criteria for TRS will be selected for study.

For the purpose of the study treatment resistant schizophrenia is

defined as:[26]

a. Failure to respond to = 2 antipsychotic.

b. Treatment failure of =1 antipsychotic + prospective treatment failure

with another antipsychotic (different from the one previously failed).

c. Dose and duration: each treatment with > 600 chlorpromazine

equivalents per day for > 6 weeks.

d. Lack of improvement in a reducing CGI > 4 and GAF < 50.

e. The duration of illness should be at least two years.

f. In addition, the patients should be resistant to clozapine provided at

adequate dose for an adequate duration.

4. Medically stable patient will be included.

5. Patients who will be accompanied by reliable informants.

6. Patients and informants who willingly participate in the study and take

ALC as augmentation therapy for TRS.

7. Patients giving written informed consent will be included.

Exclusion Criteria

EXCLUSION CRITERIA

The patients with following characteristics were excluded from study:

1. Patients who have associated medical problems, which could affect the course of illness. eg. cerebrovascular diseases, renal diseases,

pulmonary disease etc.

2. Patients of co-morbid alcohol and substance use disorder except nicotine.

3. Pregnant and breastfeeding females.

4. Violent unmanageable patients.

5. Intellectual disability patients.

6. Patients unable to cooperate on test of MoCA on first followup will be considered non eligible.

7. Patients hypersensitive to ALC.

Primary Outcome Measures

Name	Time	Method
Improvement in illness severity <br/ ><br> <br/ ><br> PANSS Score <br/ ><br> CGI Score <br/ ><br> <br/ ><br>1. Improvement in Cognition MoCA Score <br/ ><br> <br/ ><br>2. Improvement in global functioning GAF Score <br/ ><br> <br/ ><br>3. Treatment response : Defined as fall in CGI score to =2 or fall of <br/ ><br>greater than or equal to 20% score on PANSS.Timepoint: Follow-up assessment for primary and secondary <br/ ><br>outcomes will be done at baseline, 4-weeks, 8-weeks and 12-weeks.

Secondary Outcome Measures

Name	Time	Method
1.Improvement in antipsychotic side effects on AIMS and BARS scales <br/ ><br>2.Adverse event scale <br/ ><br>3.Cost effectiveness inventory <br/ ><br>Timepoint: Follow-up assessment for primary and secondary <br/ ><br>outcomes will be done at baseline, 4-weeks, 8-weeks and 12-weeks.