Comparing the effects of two medications for antipsychotic related weight gain: can adding aripiprazole or naltrexone help?

Phase 4

Conditions: Health Condition 1: F200- Paranoid schizophrenia

Registration Number: CTRI/2024/02/062617

Lead Sponsor: Madhurima Dhar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the effectiveness of Aripiprazole and Naltrexone in managing antipsychotic induced weight gain <br/ ><br> <br/ ><br>Timepoint: <br/ ><br>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 Outcome Measures

Name	Time	Method
1.To identify parameters of sociodemographic, metabolic profile, behavioral phenotype, eating behavior associated with response to aripiprazole and naltrexone. <br/ ><br>2.To study the Adverse drug reaction profile of Aripiprazole vs Naltrexone in Antipsychotic induced weight gain. <br/ ><br>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.