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CTRI Number  CTRI/2024/02/062615 [Registered on: 14/02/2024] Trial Registered Prospectively
Last Modified On: 10/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Cariprazine versus Aripiprazole on Cardiometabolic Profile in Patients with Schizophrenia Switched from Olanzapine due to Weight gain  
Scientific Title of Study   Effect of Cariprazine versus Aripiprazole on Cardiometabolic Profile in Patients with Schizophrenia Switched from Olanzapine due to 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  Adarsh Verma 
Designation  Junior Resident of Psychiatry 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  Room No. 156, First Floor, D Block, OPD Building, Department of Psychiatry, All India Institute of Medical Sciences, Phulwarisharif, Patna
Room No. 156, First Floor, D Block, OPD Building, Department of Psychiatry, All India Institute of Medical Sciences, Phulwarisharif, Patna
Patna
BIHAR
801507
India 
Phone  8081987047  
Fax    
Email  adarshverma15011998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajeev Ranjan 
Designation  Associate Professor of Psychiatry 
Affiliation  AIIMS Patna 
Address  Room No. 152, First Floor, D Block, Department of Psychiatry, OPD Building, All India Institute of Medical Sciences, Phulwarisharif, Patna
Room No. 152, First Floor, D Block, Department of Psychiatry, OPD Building, All India Institute of Medical Sciences, Phulwarisharif, Patna
Patna
BIHAR
801507
India 
Phone  8081987047  
Fax    
Email  rajeevranjan0087@gmail.com  
 
Details of Contact Person
Public Query  
Name  Adarsh Verma 
Designation  Junior Resident of Psychiatry 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  Room No. 156, First Floor, D Block, Department of Psychiatry, OPD Building, All India Institute of Medical Sciences, Phulwarisharif, Patna
Room No. 156, First Floor, D Block, Department of Psychiatry, OPD Building, All India Institute of Medical Sciences, Phulwarisharif, Patna
Patna
BIHAR
801507
India 
Phone  8081987047  
Fax    
Email  adarshverma15011998@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Phulwarisharif, Patna Pin: 801507 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  All India Institute of Medical Sciences, Phulwarishariff, Patna, Pin: 801507, Bihar 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Adarsh Verma  All India Institute of Medical Sciences Patna  Room No. 156, First floor, Department of Psychiatry, OPD Building, AIIMS, Phulwarisharif, Pin-801507
Patna
BIHAR 		 8081987047

adarshverma15011998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aripiprazole  The patient will be started with a minimum effective dose of 10 mg per day and will gradually be titrated up to 15 mg per day in 2 weeks and olanzapine will be stopped by down-titrating in 2 weeks and for a further 4 weeks, the dose of aripiprazole will be kept at 15 mg per day. In the next 6 weeks the dose will be kept between 10 and 30 mg according to improvement and worsening in patient symptoms. 
Intervention  Cariprazine  The patient will be started with a minimum effective dose of 1.5 mg per day and will gradually be titrated up to 3 mg per day in 2 weeks and olanzapine will be stopped by down-titrating in 2 weeks and for another 4 weeks, the dose of cariprazine will be kept at 3 mg per day. In the next 6 weeks, the dose will be kept between 1.5 and 6 mg, according to improvement and worsening of the patient symptoms.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient diagnosed with Schizophrenia who had received olanzapine monotherapy at a dose of 5 to 20 mg per day for a minimum 4 weeks before inclusion
Either gender
Age between 18 to 65 years
Significant weight gain greater than or equal to 7 percent during prior olanzapine therapy to be verified by medical record
Increase in weight less than 7 percent with less than 20 percent decrease in Positive and Negative Syndrome Scale score during prior olanzapine therapy for minimum of 4 weeks
Patients willing to give informed consent for the therapeutic intervention and to participate in the study
 
 
ExclusionCriteria 
Details  Patients who previously failed to respond to an adequate course of Aripiprazole (10mg to 30mg per day for greater than equal to 4 weeks) or Cariprazine (1.5 to 6 mg per day for greater than equal to 4 weeks)
Other Schizophrenia spectrum disorders
Highly agitated, suicidal patients who need immediate treatment
Co-morbid axis I psychiatric illness
Patients with co-morbid substance abuse except Nicotine use
Pregnant and nursing women
Patients with known history of diabetes mellitus- HbA1C greater than 6.5 percent,
Patients with known history of hypertension-Blood Pressure greater than equal to 130 mm Hg systolic pressure and 85 mm Hg diastolic Pressure Patients with known history of significant neurological impairment
Patient with clinical observable mental retardation
History of organicity that precludes participation in study
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in weight-It will be measured by difference in reading obtained by weighing machine at 6 weeks and 12 weeks from baseline.  Baseline and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of Aripiprazole on change in body weight with that of Cariprazine at 6 weeks of treatment in schizophrenia patients switched from olanzapine  Baseline and 6 weeks 
To compare the effect of Cariprazine on change in lipid profile, glucose metabolic RBS and HbA1c and anthropometric waist by hip ratio, Body Mass Index parameters with that of Aripiprazole at 6 and 12 weeks of treatment in schizophrenia patients switched from olanzapine  baseline, 6 weeks, 12 weeks 
To evaluate the efficacy of Cariprazine versus Aripiprazole measured by change in score by PANSS and SOFAS with that of Aripiprazole at 6 and 12 weeks of treatment in schizophrenia patients switched from olanzapine   baseline, 6 weeks, 12 weeks 
To evaluate safety of Aripiprazole and Cariprazine in patient of schizophrenia switched from olanzapine   baseline, 6 weeks, 12 weeks 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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 3/ Phase 4 
Date of First Enrollment (India)   21/02/2024 
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 Yet Recruiting 
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  

         Olanzapine and other second generation antipsychotics are efficacious in reducing symptoms of Schizophrenia but are associated with increased risk of metabolic dysfunction which result in obesity and predispose Schizophrenia patient to increased risk of cardiovascular adverse effects resulting in premature death. Dopamine Receptor partial agonist is the new class of Antipsychotics (third generation) which have very less metabolic side effects as compared to second generation Antipsychotics apart from having antipsychotic action. Using them in reducing second generation antipsychotics induced( weight gain and deranged metabolic health ) should significantly decrease metabolic health and thereby reducing premature death in Schizophrenia Patient. Literature search on PUBMED and Google scholar showed that there are limited studies conducted on effect of Cariprazine on metabolic profile in psychosis. That also, we could find it as secondary outcome of the study. There is no head on comparison of Cariprazine and Aripiprazole in ameliorating 2nd generation Antipsychotics (Olanzapine) induced weight gain and derangement of metabolic profile in Schizophrenia. Therefore aim of our study to compare the change in body weight and other cardiometabolic parameters from baseline, and after treatment at 6 weeks and at 12 weeks with Aripiprazole and Cariprazine in schizophrenia subjects switched from olanzapine. The proposed study is a prospective, open label randomized, parallel design trial and will be conducted at single tertiary care centre. The final sample size calculated is 98 (49 participants in each study arm) after considering dropout rate of 20% in the target population. Descriptive statistics in the form of mean, median, range, frequency, percentages, and standard deviation will be used. Comparison of means of continuous variables within groups will be done using repeated measures ANOVA test and between groups will be done by unpaired t test/ Mann-Whitney test. Fisher’s exact test/ t test will be used for categorical variables & continuous variables respectively for demographic data. Data will be analysed by blinded statistician using intention-to-treat (ITT) and per protocol analysis. Statistical analyses will be performed using statistical software SPSS 20.0 (IBM, NY USA) considering a significance level of P<0.05. Cariprazine may have improvement on cardiometabolic profile in Schizophrenia subjects with olanzapine induced weight gain. It may be used as alternative therapy in schizophrenia subjects with olanzapine induced weight gain.

 

 
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