Health Condition 1: F200- Paranoid schizophrenia
Conditions
Interventions
Intervention1: Treatment as usual+ Aripiprazole: Treatment arm 1 will receive Aripiprazole 5 mg per orally daily for a period of 2 months along with treatment as usual
Control Intervention1: Treatment
Sponsors
Madhurima Dhar
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who are on antipsychotic treatment for a duration of at least 3 months 2. who have gained weight by 5 % in the last 3 months. 3. All patients irrespective of gender and diagnosis 4. Female participants of childbearing potential to have a negative pregnancy test at screening and pre-dose, and willing to practice adequate methods of contraception during the study
Exclusion criteria
Exclusion criteria: 1.Those who have hypersensitivity to aripiprazole or naltrexone 2. Those who develop side effects that are bothersome including Fulminant hepatitis or extreme hypersensitivity reactions. 3. Those with uncontrolled thyroid disorder or uncontrolled diabetes mellitus. 4. Among females, those who are pregnant or lactating 5. Current alcohol or substance abuse or dependence 6. Those who used any medication for weight loss within the preceding month prior to study entry. 7. Patients who do not provide valid informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the effectiveness of Aripiprazole and Naltrexone in managing antipsychotic induced weight gain Timepoint: They will be contacted telephonically every week and will follow up in psychiatry OPD,every 2 weeks to observe for medication tolerability and side effects. Pill counting and informant report will be used to ascertain compliance to the prescribed medications. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To identify parameters of sociodemographic, metabolic profile, behavioral phenotype, eating behavior associated with response to aripiprazole and naltrexone. 2.To study the Adverse drug reaction profile of Aripiprazole vs Naltrexone in Antipsychotic induced weight gain. Timepoint: They will be contacted telephonically every week and will follow up in psychiatry OPD, every 2 weeks to observe for medication tolerability and side effects. Pill counting and informant report will be used to ascertain compliance to the prescribed medications. | — |
Countries
India
Contacts
Public ContactMadhurima Dhar
Kalinga Institute of Medical Sciences
Outcome results
None listed