| CTRI Number |
CTRI/2024/02/062617 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of two medications for antipsychotic related weight gain: can adding aripiprazole or naltrexone help? |
|
Scientific Title of Study
|
To study the efficacy and safety of Aripiprazole vs Naltrexone in managing antipsychotic induced weight gain- A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhurima Dhar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Psychiatry, PBMH Block, Kalinga Institute of Medical Sciences
Khorda
Orissa
India
Khordha
ORISSA
751024
India |
| Phone |
9547197774 |
| Fax |
|
| Email |
drmadhurimadhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ram Chandra Das |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of psychiatry,PBMH Block,KIMS
Khorda
Orissa
India
Khordha
ORISSA
751024
India |
| Phone |
9547197774 |
| Fax |
|
| Email |
r2cdpsy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhurima Dhar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of psychiatry,PBMH Block,KIMS
Khorda
Orissa
India
Khordha
ORISSA
751024
India |
| Phone |
9547197774 |
| Fax |
|
| Email |
drmadhurimadhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Madhurima Dhar |
| Address |
Kalinga Institute of Medical Sciences,PBMH Block |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhurima Dhar |
Kalinga Institute Of Medical Sciences |
Department of psychiatry,opd number 3,ground floor,PBMH Block
Khorda
Orissa
India
Khordha
ORISSA |
9547197774
drmadhurimadhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Treatment as usual + Naltrexone |
Treatment arm 2 will recieve Naltrexone 25 mg per orally daily for a period of 2 months along with treatment as usual |
| Intervention |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the effectiveness of Aripiprazole and Naltrexone in managing antipsychotic induced weight gain
|
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
|
| Outcome |
TimePoints |
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.
|
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. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The pathophysiology of antipsychotic induced weight gain is poorly understood. Aripiprazole and Naltrexone have two different mechanism of action and theoritically can benefit antipsychotic induced weight gain.This study will help to identify underlying gaps that favour response to a particular molecule thus help in identifying subgroups with a pathophysiological mechanism with indirect theraputic evidence. |