| CTRI Number |
CTRI/2024/10/074624 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A single blind randomised controlled trial comparing the efficacy and safety of low dose cariprazine vs olanzapine-fluoxitine combination in patients with bipolar depression-II |
|
Scientific Title of Study
|
A single blind randomised controlled trial to determine the relative efficacy and safety of
low dose cariprazine vs olanzapine-fluoxitine fixed dose combination in patients with acute bipolar depression-II |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avi jindal |
| Designation |
Juniour resident |
| Affiliation |
Government medical college and Rajindra hospital Patiala |
| Address |
Room no 3 department of psychiatry Government medical college and Rajindra hospital patiala147001 Sangrur road Punjab India
Hno 77 Bank colony Patiala 147001 Punjab India
Patiala
PUNJAB
147001
India |
| Phone |
7888416799 |
| Fax |
|
| Email |
aviijindal97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rajnish raj |
| Designation |
Professor and head |
| Affiliation |
Government medical college and Rajindra hospital Patiala |
| Address |
Room no 1 Department of psychiatry Government medical college and Rajindra hospital Patiala 147001Sangrur road PUNJAB India
Model deaddiction centre Rajindra hospital Patiala 147001 Sangrur road Punjab India
Patiala
PUNJAB
147001
India |
| Phone |
9814913599 |
| Fax |
|
| Email |
Profheadpsy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit garg |
| Designation |
Professor |
| Affiliation |
Government medical college and Rajindra hospital Patiala |
| Address |
Room no 10 Department of psychiatry Government medical college and Rajindra hospital Patiala 147001 Sangrur road Punjab India
New sst nagar Rajpura road Patiala 147001 Punjab India
Patiala
PUNJAB
147001
India |
| Phone |
9888145477 |
| Fax |
|
| Email |
jrpsychiatry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of psychiatry Government medical college and Rajindra hospital Patiala 147001 Sangrur road India |
|
|
Primary Sponsor
|
| Name |
Government medical college Patiala Punjab |
| Address |
Government Medical College Rajindra hospital Patiala 147001 Sangrur road Punjab India |
| Type of Sponsor |
Government medical college |
|
|
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 Avi jindal |
Government medical college Patiala |
Room no 3 Department of psychiatry Government medical college and Rajindra hospital Patiala 147001 Sangrur road Punjab India
Patiala
PUNJAB |
7888416799
aviijindal97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVT. MEDICAL COLLEGE PATIALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A single blinded randomised controlled trial to determine the relative efficacy and safety of low dose cariprazine |
Group A will be recieving low dose cariprazine 1.5-3mg per day by oral route, once daily, till 8 weeks. Their sociodemographic data will be recorded through various parameters like YMRS,BDRS,CGI-BP,WHOQoL-Brefscore,Body weight(KG), Height(m), BMI(kg/msq), BP(mmHg), Fasting lipid profile which includes-TC,TG,LDL,VLDL,HDL,TG:HDL,TC:HDL,Fasting blood sugar HBA1C,ESRS Score, ADR reporting details. All these are done at 1st visit(Baseline), visit 2(week 2), visit3(week 4), visit 4(week 6), visit 5(week 8). Total duration of study will be 8 weeks. |
| Comparator Agent |
Olanzapine fluoxitine fixed dose combination in patients with Acute bipolar depresion-II |
Group B will be recieveng olanzapine fluoxitine combination 5/20mg-10/40mg per day by oral route, once daily,for 8 weeks.Their sociodemographic data will be recorded through various parameters like YMRS,BDRS,CGI-BP,WHOQoL-Brefscore,Body weight(KG), Height(m), BMI(kg/msq), BP(mmHg), Fasting lipid profile which includes-TC,TG,LDL,VLDL,HDL,TG:HDL,TC:HDL,Fasting blood sugar HBA1C,ESRS Score, ADR reporting details. All these are done at 1st visit(Baseline), visit 2(week 2), visit3(week 4), visit 4(week 6), visit 5(week 8). Total duration of study will be 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 18 to 65 years.
2. Patients suffering from acute bipolar-II depression as per ICD-11 criteria.
3. Patients who will be medically stable.
4. Patients who will be accompanied by reliable informants.
5. Patients and informants who give written informed consent and are willing
participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have associated medical illness, which could affect the course of
illness e.g., T2DM, hypertension, pulmonary/cardiovascular/renal illnesses.
2. History of substance use disorder in the last six months.
3. Patient on other psychiatric medication which may interfere in assessing
treatment response by the principal drug:-
a. Mood stabalizers, e.g., Lithium, Divalproex, Carbamazepine, Lamotrigine.
b. Other Antipsychotics, e.g., Quetiapine, Lurasidone, Risperidone,
Amisulpiride, etc.
c. Other Antidepressants, e.g., SSRIs other than Fluoxetine, SNRIs and
atypical antidepressants.
For this purpose, a 2-week washout period for any of the above drugs will be
carried out with the permission and written consent of patient and caregiver.
4. Any other co-morbid psychiatric illness.
5. Patients requiring multiple psychotropics (except adjunct medication i.e. BZD/
Propranolol).
6. Pregnant and Breastfeeding females.
7. Patients with Intellectual disability.
8. Patients with history of epilepsy, or other organic/ neurological disorder.
9. Hypersensitivity to low-dose Cariprazine or OFC as applicable.
10.Refusal to give written informed consent.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the therapeutic efficacy of low-dose Cariprazine and OFC in acute
bipolar-II depression |
Therapeutic efficacy will be determined in the visit one(baseline), week 2, week 4, week 6, week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the at-risk metabolic factors in terms of side effect profile due to lowdose Cariprazine an |
Therapeutic efficacy will be determined in the visit one(baseline), week 2, week 4, week 6, week 8 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 |
|
Date of First Enrollment (India)
|
06/10/2024 |
| 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
|
Bipolar disorder is a complex psychiatric illness characterized by the presence of alternating episodes of mania or hypomania and depression. While both manic and depressive episodes can have significant impact on an individual’s life, depression is a particularly challenging aspect of bipolar disorder. Bipolar depression is associated with high rates of morbidity, disability and suicide. One of the most effective treatment options available for bipolar depression is Olanzapine-Fluoxetine Fixed-dose Combination (OFC) as per the standard international guidelines. However, it causes significant weight gain, and cardio-vascular morbidity which decreases compliance. Effective treatment options for this aspect are urgently needed, which includes the recently US Food and Drug Administration (US-FDA) approved drug for bipolar depression, that is low-dose Cariprazine. The aim of this study will be to compare the efficacy and safety of two drugs i.e., low-dose Cariprazine and OFC in patients with acute Bipolar-II depression It will be a hospitalbased, interventional, comparative and prospective follow-up, single-blind randomized trial (N=140). Patients will be taken from both OPD and IPD of Psychiatry Department of G.M.C. and Rajindra Hospital, Patiala. They will be divided into two groups of 70 each. Group A (low-dose Cariprazine) and Group B (OFC) will Page 13 of 92 be evaluated at baseline, 2 weeks, 4 weeks and 6 weeks and 8 weeks. Primary outcome measures will be therapeutic response on Bipolar Depression Rating Scale (BDRS) and Clinical Global Impressions- Bipolar (CGI-BP) scales and improvement in quality of life on the World Health Organization Quality of Life- Brief version (WHOQoL-Bref). Secondary outcome will be treatment emergent adverse events (TEAEs) including physical parameters of body weight (kg), body mass index (BMI), blood pressure (BP), lab investigations of fasting blood sugar (FBS), fasting lipid profile (FLP) and glycosylated hemoglobin (HbA1c), manic switch on Young‟s Mania Rating Scale (YMRS), extrapyramidal adverse effects on ESRS score and other adverse events on the Indian Pharmacopoeia ADR reporting form. Data will be analyzed by relevant tests wherever applicable at statistically significant p value <0.05. |