Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: ACETYL-L-CARNITINE AS AUGMENTATION THERAPY IN CLOZAPINE RESISTANT SCHIZOPHRENIA:
Schizophrenia is a chronic disorder associated with wide range of manifestations in several psychopatho
and illness duration more than 2 years. The antipsychotic Clozapine is the drug of choice for management of TRS. Many patients however do not respond to Clozapine monotherapy and require to be adminis
Sponsors
Government Medical College Patiala
Eligibility
Inclusion criteria
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 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in illness severity PANSS Score CGI Score 1. Improvement in Cognition MoCA Score 2. Improvement in global functioning GAF Score 3. Treatment response : Defined as fall in CGI score to =2 or fall of greater than or equal to 20% score on PANSS.Timepoint: Follow-up assessment for primary and secondary outcomes will be done at baseline, 4-weeks, 8-weeks and 12-weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement in antipsychotic side effects on AIMS and BARS scales 2.Adverse event scale 3.Cost effectiveness inventory Timepoint: Follow-up assessment for primary and secondary outcomes will be done at baseline, 4-weeks, 8-weeks and 12-weeks. | — |
Countries
India
Contacts
Public ContactDr Dilsohoj Kaur
Rajindra Hospital Patiala
Outcome results
None listed