| CTRI Number |
CTRI/2026/01/100356 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of a Long-Acting Injection of Cariprazine (Cariprazine Depot) for PK, Safety, Tolerability and Efficacy |
|
Scientific Title of Study
|
A prospective, dose escalating, open label, multi-center, Phase I/IIa study to to evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in in subjects eligible for treatment with oral Cariprazine. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Mapi Cariprazine Depot Phase I/IIa-001 V2 Dated 22-Oct-2024 |
Protocol Number |
| NCT07185815 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President – Clinical Operations |
| Affiliation |
CBCC Global Research |
| Address |
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle
Ahmadabad
GUJARAT
382210
India |
| Phone |
09637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President – Clinical Operations |
| Affiliation |
CBCC Global Research |
| Address |
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle
GUJARAT
382210
India |
| Phone |
09637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Vice President – Clinical Operations |
| Affiliation |
CBCC Global Research |
| Address |
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle
GUJARAT
382210
India |
| Phone |
09637555304 |
| Fax |
|
| Email |
sandeep.singh@cbccusa.com |
|
|
Source of Monetary or Material Support
|
| Mapi Pharma Ltd
16 Einstein St.Ness-Ziona, Israel 7403620
Tel No:972-73-7121213
|
|
|
Primary Sponsor
|
| Name |
Mapi Pharma Ltd |
| Address |
16 Einstein St. Ness-Ziona, Israel 7403620
Tel No: 972-73-7121213
|
| Type of Sponsor |
Other [Pharmaceutical Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CBCC Global Research LLP |
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd,
Opp. Apple Woods, Near Shantipura circle, Ahmedabad – 382210, Gujarat, India.
|
|
|
Countries of Recruitment
|
India
Israel |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minakshi Parikh |
B.J. Medical College and Civil Hospital |
Room No: 133, Department of Psychiatry, First Floor, OPD building, B.J. Medical College and Civil Hospital, Asarwa, Ahmedabad-380016
Ahmadabad
GUJARAT |
9825718698
drminakshiparikh@gmail.com |
| Dr Vaishal Vora |
Ratandeep Multispeciality Hospital |
Room No: NA, Department of Psychiatry, 2nd, 3rd & 5th Floor, Nakshatra Complex, above HDFC Bank, Maninagar-Cross Road, Maninagar, Ahmedabad-380008, Gujarat, India
Ahmadabad
GUJARAT |
9825440891
vaishal.vora@ratandeepmsh.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| B. J. Medical College And Civil Hospital |
Approved |
| Ratandeep Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, (2) ICD-10 Condition: F319||Bipolar disorder, unspecified, (3) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cohort 3 |
Dose: 22 mg or 44 mg based on outcome of Cohort 1 & Cohort 2
Frequency: Three monthly doses
Route of Administration: Subcutaneous
Duration of Therapy: 84 Days
|
| Intervention |
Cohorts 1 and 2: |
Dose: 22 mg (Cohort 1)/44 mg (Cohort 2)
Frequency: Single dose
Route of Administration: Subcutaneous
Total Duration of intervention: 28 Days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Key Inclusion Criteria:
Subjects who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to cohorts 1 and 2 only).
Clinically stable subjects (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than Cariprazine for at least 4 weeks, prior to screening), receiving antipsychotic/s or antidepressant/s other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg/day, with CGI-S score of 0-4.
Men and women aged 18-64 years (inclusive).
Body mass index (BMI) 18.5-35.
Able to sign an informed consent form.
Adult subjects with a current diagnosis of schizophrenia, who meet DSM-5-TR diagnostic criteria for schizophrenia, naïve to or treated with antipsychotics (this inclusion criterion relates to cohort 3 only).
|
|
| ExclusionCriteria |
| Details |
Key Exclusion Criteria:
Subjects with schizophrenia with PANSS item scores of greater than 4 on any of the following: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.
Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders.
Use of an investigational drug, and/or participation in clinical studies with an investigational product within 3 months prior to screening.
History or current cardiovascular or cerebrovascular disease.
History of seizures or conditions that lower the seizure threshold.
Use of concomitant administration of strong or moderate CYP3A4 inhibitors.
Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated.
Subjects with Suicidal Thoughts and Behaviors or has a history of suicidal ideation in the past year, or made a suicide attempt in the past 5 years.
Subjects with a history of orthostatic hypotension and/or syncope.
Subjects clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only).
Subjects with CGI-S score of 5-7.
Subjects previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia.
For cohort 3 only: Subjects treated with oral Clozapine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral Cariprazine. |
Safety, rate of adverse events (AEs) [Time Frame: Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort]
Plasma concentration of cariprazine and its active metabolites [Time Frame: Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NA |
Tolerability: Incidence & severity of injection site reactions [Through study completion, up to 22 weeks for each subject in the first 2 cohorts & up to 24 weeks for each subject in the 3rd cohort]
Efficacy - Cohort 3: Positive & Negative Symptom Score (PANSS) [Through study completion, up to 24 weeks for each subject in the 3rd cohort]
Efficacy - Cohort 3: Clinical Global Impression Scale (CGI) [Through study completion, up to 24 weeks for each subject in the 3rd cohort]
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="18"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a Phase I/IIa study, aimed to assess the safety, tolerability and PK of Cariprazine Depot escalating doses of 22 mg and 44 mg as a single dose. Following the determination of the Maximum Tolerated Dose (MTD), based on the safety data from cohorts 1 and 2, Cariprazine Depot dose for cohort 3 will be determined. The selection of the dose for cohort 3 will depend on both the MTD and the PK profile. Twenty four subjects diagnosed with schizophrenia will be enrolled in the 3rd cohort. In addition, it is aimed to assess the safety, tolerability, PK and efficacy of the MTD of Cariprazine Depot, administered once every 4 weeks in a 12-week treatment period. Primary Endpoints: • Safety, rate of adverse events (AEs) • PK Profile Secondary Endpoints: • Tolerability • Efficacy (cohort 3 only) Safety and tolerability outcome measures will be evaluated: Safety: • Adverse events. • Vital signs. • ECG findings.
• Laboratory parameters, etc. Tolerability: Incidence and severity of injection site reactions.
Efficacy:
Positive and Negative Symptom Score (PANSS), 30-item scale - a validated, multi-item inventory, composed of three subscales to evaluate positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression, scores range from 30 to 210, where higher values represent a worse outcome. Clinical Global Impression-Severity scale, a validated clinician-related scale from 1 to 7, measures the patient’s current illness state and overall clinical state, where higher values represent a worse outcome. The Clinical Global Impression-Severity (CGI-S) and improvement (CGI-I) scales score will be summarized by treatment group and by visit.
|