Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia
NCT ID: NCT03160521
Last Updated: 2022-02-22
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
438 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-06-02
Study Completion Date
2018-12-17
Brief Summary
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This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or 100 mg) or placebo, in patients with acute exacerbation of schizophrenia.
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Detailed Description
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The study design includes a screening period, a 12-week treatment period, and a follow-up period. Eligible patients will be randomly assigned, under double-blind conditions, to receive the following study drug treatments in a 1:1:1 ratio during the double-blind treatment period: Risperidone ISM® 75 mg, Risperidone ISM® 100 mg, or placebo. The IM study drug (double-blind active Risperidone ISM® or placebo) will be administered in a deltoid or gluteal muscle for a total of 3 times, once every 4 weeks, during the 12-week treatment period.
If indicated for an individual patient, prohibited medications may be washed out during the screening period. Patients who have never taken Risperidone must have a brief trial of oral Risperidone in order to ensure a lack of any clinically significant hypersensitivity reactions before the first dose of the study drug is administered.
Efficacy will be assessed by describing changes in scores on standard psychiatric assessment tools at each visit. Safety assessments will also be conducted at each visit.
The primary objective of this study is the following:
• To evaluate the efficacy of Risperidone ISM as compared with that of placebo in the treatment of patients with acute exacerbation of schizophrenia
The secondary objectives of this study are the following:
* To characterize safety and tolerability of Risperidone ISM as compared with that of placebo in patients with acute exacerbation of schizophrenia
* To quantify healthcare resource utilization (HRU), health-related quality of life (HRQL), and social functioning in patients treated with Risperidone ISM versus placebo for an acute exacerbation of schizophrenia
* To explore pharmacokinetic characteristics of Risperidone ISM and associations with efficacy
Patients who complete planned double-blind study drug treatments and study evaluations may be eligible to participate in an optional long-term extension segment of the study in which treatment with open-label Risperidone ISM 75 or 100 mg (randomly assigned) would begin immediately; for patients who do not participate in the extension segment, a safety follow-up phone contact will occur after the end-of-treatment visit.
In addition to patients continuing from the double-blind segment of the study (rollover patients), patients not previously enrolled in the study (de novo patients) may be eligible to enter the long-term extension segment of the study. These patients will be evaluated for eligibility at a screening visit and, if eligible, will be allocated to receive either 75 or 100 mg Risperidone ISM every 4 weeks for approximately 12 months.
If indicated for an individual patient, prohibited medications may be washed out during the screening period. Patients who have never taken Risperidone must have a brief trial of oral Risperidone in order to ensure a lack of any clinically significant hypersensitivity reactions before the first dose of the study drug is administered.
Efficacy will be assessed by describing changes in scores on standard psychiatric assessment tools at each visit. Safety assessments will also be conducted at each visit.
The primary objective of this study is the following:
• To evaluate the efficacy of Risperidone ISM as compared with that of placebo in the treatment of patients with acute exacerbation of schizophrenia
The secondary objectives of this study are the following:
* To characterize safety and tolerability of Risperidone ISM as compared with that of placebo in patients with acute exacerbation of schizophrenia
* To quantify healthcare resource utilization (HRU), health-related quality of life (HRQL), and social functioning in patients treated with Risperidone ISM versus placebo for an acute exacerbation of schizophrenia
* To explore pharmacokinetic characteristics of Risperidone ISM and associations with efficacy
Patients who complete planned double-blind study drug treatments and study evaluations may be eligible to participate in an optional long-term extension segment of the study in which treatment with open-label Risperidone ISM 75 or 100 mg (randomly assigned) would begin immediately; for patients who do not participate in the extension segment, a safety follow-up phone contact will occur after the end-of-treatment visit.
In addition to patients continuing from the double-blind segment of the study (rollover patients), patients not previously enrolled in the study (de novo patients) may be eligible to enter the long-term extension segment of the study. These patients will be evaluated for eligibility at a screening visit and, if eligible, will be allocated to receive either 75 or 100 mg Risperidone ISM every 4 weeks for approximately 12 months.
Conditions
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Acute Schizophrenia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
The study drug will be administered under double-blind conditions so that investigators, site staff, and patients will not be aware about the identity of the study drug (ie, blinded Risperidone ISM 75 mg, Risperidone ISM 100 mg, or placebo) administered to any given patient.
Study Groups
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Risperidone ISM 75 mg
Patients assigned to this arm will received 75 mg of Risperidone ISM during double-blind treatment period.
Group Type
EXPERIMENTAL
Risperidone ISM 75 mg
Intervention Type
DRUG
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Risperidone ISM 100 mg
Patients assigned to this arm will received 100 mg of Risperidone ISM during double-blind treatment period.
Group Type
EXPERIMENTAL
Risperidone ISM 100 mg
Intervention Type
DRUG
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Placebo
Patients assigned to this arm will received placebo of Risperidone ISM during double-blind treatment period.
Group Type
PLACEBO_COMPARATOR
Placebo of Risperidone ISM
Intervention Type
DRUG
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Interventions
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Risperidone ISM 75 mg
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Intervention Type
DRUG
Risperidone ISM 100 mg
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Intervention Type
DRUG
Placebo of Risperidone ISM
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Intervention Type
DRUG
Other Intervention Names
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Risperidone ISM
Risperidone ISM
PLACEBO
Eligibility Criteria
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Inclusion Criteria
To be eligible for enrolment into the study, each patient must meet all of the following criteria at screening:
1. Capable of providing informed consent
1. A signed informed consent form must be provided before any study assessments are performed
2. Patients must be fluent in the language that is spoken by the investigator and the study site staff (including raters) and must be able to read and understand the words in which the informed consent is written
2. Age ≥ 18 and ≤ 65 years
3. Body mass index 18.5 to 40.0 kg/m2 (inclusive)
4. Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
1. Currently experiencing an acute exacerbation or relapse with onset \< 2 months before screening
2. If inpatient at screening, has been hospitalized for \< 2 weeks for the current exacerbation
3. ≥ 2 years have elapsed since initial onset of active-phase schizophrenia symptoms
5. Has been able to achieve outpatient status for \> 4 months during the past year
6. Has previously had a clinically significant beneficial response (improvement in schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine
7. Agrees to discontinue prohibited medications as applicable and as clinically indicated according to investigator instructions
8. Dosages of all permitted medications are considered to have been stable (with the exception of medication to be used on an as-needed basis) for ≥ 2 weeks prior to the baseline visit and to remain stable during participation in this study
9. Positive and Negative Syndrome Scale (PANSS) results at the screening and baseline visits meets the following criteria:
a. Total score between 80 and 120, inclusive b. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale items: i. Item 1 (P1: delusions) ii. Item 2 (P2: conceptual disorganization) iii. Item 3 (P3: hallucinatory behavior) iv. Item 6 (P6: suspiciousness/persecution)
10. Clinical Global Impression - Severity (CGI-S) score of ≥ 4 (moderately ill or worse)
11. Resides in a stable living situation and is anticipated to return to that same stable living situation after discharge from the inpatient study unit, in the opinion of the investigator
12. Has an identified reliable informant who is anticipated to remain the same after the patient is discharged from the inpatient study unit, in the opinion of the investigator
13. Meets the following criteria:
a. If a sexually active, is using a medically accepted contraceptive method, and will continue to use such throughout participation in this study (and for ≥ 6 months after the last dose of IM study drug has been administered); acceptable methods include the following: i. Condoms (male or female) with or without a spermicidal agent ii. Diaphragm or cervical cap with spermicide iii. Intrauterine device iv. Hormonal contraceptive b. If not currently sexually active, them meets the following criteria: i. Agrees that if sexually activity resumes while participating in this study, a medically accepted contraception method will be used
14. Willing and able to be confined to an inpatient study unit for up to 2 weeks (or longer if clinically indicated), as applicable and as clinically indicated according to investigator instructions
15. Agrees not to post any personal medical data related to the study or information related to the study on any website or social media site (eg, Facebook, Twitter, and others) during the study duration
1. Capable of providing informed consent
1. A signed informed consent form must be provided before any study assessments are performed
2. Patients must be fluent in the language that is spoken by the investigator and the study site staff (including raters) and must be able to read and understand the words in which the informed consent is written
2. Age ≥ 18 and ≤ 65 years
3. Body mass index 18.5 to 40.0 kg/m2 (inclusive)
4. Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
1. Currently experiencing an acute exacerbation or relapse with onset \< 2 months before screening
2. If inpatient at screening, has been hospitalized for \< 2 weeks for the current exacerbation
3. ≥ 2 years have elapsed since initial onset of active-phase schizophrenia symptoms
5. Has been able to achieve outpatient status for \> 4 months during the past year
6. Has previously had a clinically significant beneficial response (improvement in schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine
7. Agrees to discontinue prohibited medications as applicable and as clinically indicated according to investigator instructions
8. Dosages of all permitted medications are considered to have been stable (with the exception of medication to be used on an as-needed basis) for ≥ 2 weeks prior to the baseline visit and to remain stable during participation in this study
9. Positive and Negative Syndrome Scale (PANSS) results at the screening and baseline visits meets the following criteria:
a. Total score between 80 and 120, inclusive b. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale items: i. Item 1 (P1: delusions) ii. Item 2 (P2: conceptual disorganization) iii. Item 3 (P3: hallucinatory behavior) iv. Item 6 (P6: suspiciousness/persecution)
10. Clinical Global Impression - Severity (CGI-S) score of ≥ 4 (moderately ill or worse)
11. Resides in a stable living situation and is anticipated to return to that same stable living situation after discharge from the inpatient study unit, in the opinion of the investigator
12. Has an identified reliable informant who is anticipated to remain the same after the patient is discharged from the inpatient study unit, in the opinion of the investigator
13. Meets the following criteria:
a. If a sexually active, is using a medically accepted contraceptive method, and will continue to use such throughout participation in this study (and for ≥ 6 months after the last dose of IM study drug has been administered); acceptable methods include the following: i. Condoms (male or female) with or without a spermicidal agent ii. Diaphragm or cervical cap with spermicide iii. Intrauterine device iv. Hormonal contraceptive b. If not currently sexually active, them meets the following criteria: i. Agrees that if sexually activity resumes while participating in this study, a medically accepted contraception method will be used
14. Willing and able to be confined to an inpatient study unit for up to 2 weeks (or longer if clinically indicated), as applicable and as clinically indicated according to investigator instructions
15. Agrees not to post any personal medical data related to the study or information related to the study on any website or social media site (eg, Facebook, Twitter, and others) during the study duration
Exclusion Criteria
An individual who meets any of the following criteria at screening will not be permitted to enroll in the study:
1. History of proven inadequate clinical response to treatment with therapeutic doses (with good compliance) of risperidone or paliperidone
2. History of treatment resistance, defined as failure to respond to 2 discrete adequate trials (≥ 4 weeks with an adequate dose) of 2 different antipsychotic medications; history of clozapine use (exception: use was not because of treatment resistance or refractory psychotic symptoms)
3. Improvement in PANSS total score 20% or greater between the initial screening visit and first injection
4. Known or suspected intolerance of or allergy or hypersensitivity to risperidone, paliperidone, or any of the excipients in the IM formulations of these
5. History of neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or tardive dystonia
6. History of any other medical condition that is considered to pose any unjustifiable risk or interfere with study assessments
7. Clinically significant extrapyramidal symptoms at screening or baseline
8. Answer of "yes" on item 4 or on item 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (ideation) with the most recent episode occurring within the past 2 months, or answer "yes" to any of the 5 items (behavior) with an episode occurring within the last year
9. Current diagnosis or a history of substance use disorder according to DSM-5 criteria within 6 months prior to the screening visit (with the exception of tobacco, mild cannabis, or mild alcohol use disorder) or a positive drug screen test (with the exception of cannabis) verified by repeat testing
10. Lifetime history of diagnosis of schizoaffective disorder or bipolar disorder
11. Clinically significant comorbid neuropsychiatric disorders including any of the following:
1. Current untreated or unstable major depressive disorder
2. Clinically significant cognitive difficulties including dementia, delirium, or amnesic syndrome, within the past 2 years and would interfere with participation in the study
3. Any other psychiatric condition that would, in the judgment of the investigator, interfere with participation in the study
12. Clinically significant or unstable medical illness/condition/disorder that would be anticipated, in the investigator's opinion, to potentially compromise patient safety or adversely affect the evaluation of efficacy, including (but not necessarily limited to) the following:
1. Clinically significant hypotension or hypertension not stabilized by medical therapy (diastolic blood pressure \> 105 mmHg)
2. Unstable thyroid dysfunction in the past 6 months
3. Malignant tumor within the last 5 years
4. Neurologic conditions including the following:
i. History of seizure disorder or condition associated with seizures ii. History of brain tumor, subdural hematoma, or other clinically significant neurological condition within the past 12 months iii. Head trauma with loss of consciousness within 12 months before screening iv. Active acute or chronic central nervous system infection v. Stroke within 6 months before screening e. Cardiac conditions including the following: i. Clinically significant cardiac arrhythmia, cardiomyopathy, or cardiac conduction defect ii. History of myocardial infarction or unstable angina within the last 3 months before screening, or clinically significant abnormality on screening or baseline electrocardiogram (ECG) including but not limited to the following: QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 465 msec if male or \> 485 msec if female
13. Laboratory abnormality that, in the opinion of the investigator, would compromise the well-being of the patient, or any of the following laboratory abnormalities at screening or baseline:
1. Aspartate aminotransferase or alanine aminotransferase value ≥ 2 times the upper limit of the laboratory normal reference range
2. Hemoglobin A1c \> 9%
3. Absolute neutrophil count ≤ 1.5 × 103 μL
4. Platelet count ≤ 75 × 103 μL
5. Creatinine clearance \< 60 mL/min
6. Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or antihepatitis C virus antibody
7. Positive pregnancy test result
8. Urine drug screen at screening or baseline shows a positive result for any of the tested substances (potential exceptions: results positive for benzodiazepine may not be exclusionary if the investigator confirms that such medication was medically indicated and consults the medical monitor before enrolling a patient with such a finding; results positive for Tetrahydrocannabinol (THC) may not be exclusionary in certain cases only if exclusion criterion 9 is not met and only if the medical monitor provides approval)
14. Pregnant, lactating, or breastfeeding
15. Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections
16. Any contraindication for IM injections
17. Receipt of any long-acting antipsychotic medication by IM injection within 60 days before screening
18. Current involuntary hospitalization or incarceration
19. Hospitalized for more than 30 days during the 90 days before screening
20. Participation in another clinical study in which the patient received an experimental or investigational drug or agent within 6 months before screening
21. Participation in a clinical study with Risperidone ISM within 1 year before screening
22. Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons
23. Patients taking any prohibited concomitant medication (see Section 3.2.2.1.1) at the time of randomization visit
24. Clinically significant ocular disease or visual impairment interfering with the planned ophthalmological examinations or that in the investigator's opinion could potentially compromise patients' ocular safety
25. Patients with planned or anticipated need for ocular surgery during the treatment period of the trial
1. History of proven inadequate clinical response to treatment with therapeutic doses (with good compliance) of risperidone or paliperidone
2. History of treatment resistance, defined as failure to respond to 2 discrete adequate trials (≥ 4 weeks with an adequate dose) of 2 different antipsychotic medications; history of clozapine use (exception: use was not because of treatment resistance or refractory psychotic symptoms)
3. Improvement in PANSS total score 20% or greater between the initial screening visit and first injection
4. Known or suspected intolerance of or allergy or hypersensitivity to risperidone, paliperidone, or any of the excipients in the IM formulations of these
5. History of neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or tardive dystonia
6. History of any other medical condition that is considered to pose any unjustifiable risk or interfere with study assessments
7. Clinically significant extrapyramidal symptoms at screening or baseline
8. Answer of "yes" on item 4 or on item 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (ideation) with the most recent episode occurring within the past 2 months, or answer "yes" to any of the 5 items (behavior) with an episode occurring within the last year
9. Current diagnosis or a history of substance use disorder according to DSM-5 criteria within 6 months prior to the screening visit (with the exception of tobacco, mild cannabis, or mild alcohol use disorder) or a positive drug screen test (with the exception of cannabis) verified by repeat testing
10. Lifetime history of diagnosis of schizoaffective disorder or bipolar disorder
11. Clinically significant comorbid neuropsychiatric disorders including any of the following:
1. Current untreated or unstable major depressive disorder
2. Clinically significant cognitive difficulties including dementia, delirium, or amnesic syndrome, within the past 2 years and would interfere with participation in the study
3. Any other psychiatric condition that would, in the judgment of the investigator, interfere with participation in the study
12. Clinically significant or unstable medical illness/condition/disorder that would be anticipated, in the investigator's opinion, to potentially compromise patient safety or adversely affect the evaluation of efficacy, including (but not necessarily limited to) the following:
1. Clinically significant hypotension or hypertension not stabilized by medical therapy (diastolic blood pressure \> 105 mmHg)
2. Unstable thyroid dysfunction in the past 6 months
3. Malignant tumor within the last 5 years
4. Neurologic conditions including the following:
i. History of seizure disorder or condition associated with seizures ii. History of brain tumor, subdural hematoma, or other clinically significant neurological condition within the past 12 months iii. Head trauma with loss of consciousness within 12 months before screening iv. Active acute or chronic central nervous system infection v. Stroke within 6 months before screening e. Cardiac conditions including the following: i. Clinically significant cardiac arrhythmia, cardiomyopathy, or cardiac conduction defect ii. History of myocardial infarction or unstable angina within the last 3 months before screening, or clinically significant abnormality on screening or baseline electrocardiogram (ECG) including but not limited to the following: QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 465 msec if male or \> 485 msec if female
13. Laboratory abnormality that, in the opinion of the investigator, would compromise the well-being of the patient, or any of the following laboratory abnormalities at screening or baseline:
1. Aspartate aminotransferase or alanine aminotransferase value ≥ 2 times the upper limit of the laboratory normal reference range
2. Hemoglobin A1c \> 9%
3. Absolute neutrophil count ≤ 1.5 × 103 μL
4. Platelet count ≤ 75 × 103 μL
5. Creatinine clearance \< 60 mL/min
6. Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or antihepatitis C virus antibody
7. Positive pregnancy test result
8. Urine drug screen at screening or baseline shows a positive result for any of the tested substances (potential exceptions: results positive for benzodiazepine may not be exclusionary if the investigator confirms that such medication was medically indicated and consults the medical monitor before enrolling a patient with such a finding; results positive for Tetrahydrocannabinol (THC) may not be exclusionary in certain cases only if exclusion criterion 9 is not met and only if the medical monitor provides approval)
14. Pregnant, lactating, or breastfeeding
15. Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections
16. Any contraindication for IM injections
17. Receipt of any long-acting antipsychotic medication by IM injection within 60 days before screening
18. Current involuntary hospitalization or incarceration
19. Hospitalized for more than 30 days during the 90 days before screening
20. Participation in another clinical study in which the patient received an experimental or investigational drug or agent within 6 months before screening
21. Participation in a clinical study with Risperidone ISM within 1 year before screening
22. Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons
23. Patients taking any prohibited concomitant medication (see Section 3.2.2.1.1) at the time of randomization visit
24. Clinically significant ocular disease or visual impairment interfering with the planned ophthalmological examinations or that in the investigator's opinion could potentially compromise patients' ocular safety
25. Patients with planned or anticipated need for ocular surgery during the treatment period of the trial
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Rovi Pharmaceuticals Laboratories
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Robert Litman
Role: PRINCIPAL_INVESTIGATOR
CBH Health LLC
Yuriy Filts
Role: PRINCIPAL_INVESTIGATOR
CI Lviv Regional Clinical Psychiatric Hospital. Department 25
Locations
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Woodland Research Northwest
Rogers, Arkansas, United States
Site Status
CIMU Bellflower
Cerritos, California, United States
Site Status
Collaborative Neuroscience Network, LLC.
Garden Grove, California, United States
Site Status
Synergy Research San Diego
Lemon Grove, California, United States
Site Status
Apostle Clinical Trials
Long Beach, California, United States
Site Status
NRC Research Institute
Orange, California, United States
Site Status
CNRI-Los Angeles LLC
Pico Rivera, California, United States
Site Status
CNRI-San Diego
San Diego, California, United States
Site Status
Galiz Research
Hialeah, Florida, United States
Site Status
Innovative Clinical Research Inc.
Hollywood, Florida, United States
Site Status
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Site Status
CBH Health LLC
Gaithersburg, Maryland, United States
Site Status
Precise Research Centers MS
Flowood, Mississippi, United States
Site Status
Altea Research Institute
Las Vegas, Nevada, United States
Site Status
Hassman Research Institute
Berlin, New Jersey, United States
Site Status
Midwest Clinical Research Center
Dayton, Ohio, United States
Site Status
Carolina Clinical Triasl Inc
Charleston, South Carolina, United States
Site Status
Community Clinical Research Inc.
Austin, Texas, United States
Site Status
InSite Clinical Research
DeSoto, Texas, United States
Site Status
Pillar Clinical Research LLC
Richardson, Texas, United States
Site Status
Regional Clinical Hospital n.a I.I. Mechnicov
Dnipro, , Ukraine
Site Status
Kharkiv Regional Clinical Psychiatric Hospital
Kharkiv, , Ukraine
Site Status
Public Healthcare Institution "Kharkiv Regional Clinical Psychiatric Hospital No. 3", Center of Urgent Psychiatry
Kharkiv, , Ukraine
Site Status
Kherson Regional Psychiatric Hospital
Kherson, , Ukraine
Site Status
Kiev City Psychiatric Hospital No. 2
Kiev, , Ukraine
Site Status
Kyiv Regional Medical Association "Psykhiatriya" in Kyiv
Kiev, , Ukraine
Site Status
CI Lviv Regional Clinical Psychiatric Hospital. Department 20
Lviv, , Ukraine
Site Status
CI Lviv Regional Clinical Psychiatric Hospital. Department 25
Lviv, , Ukraine
Site Status
Odesa Regional Medical Centre of Mental Health
Odesa, , Ukraine
Site Status
Maltsev Regional Clinical Psychiatric Ho
Poltava, , Ukraine
Site Status
N.I. Pyrogov Vinnytsya Natl Medical University
Vinnytsia, , Ukraine
Site Status
Countries
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United States
Ukraine
References
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Correll CU, Litman RE, Filts Y, Llaudo J, Naber D, Torres F, Martinez J. Efficacy and safety of once-monthly Risperidone ISM(R) in schizophrenic patients with an acute exacerbation. NPJ Schizophr. 2020 Nov 25;6(1):37. doi: 10.1038/s41537-020-00127-y.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ROV-RISP-2016-01
Identifier Type: -
Identifier Source: org_study_id
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Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
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COMPLETED
PHASE4
Risperidone and Suicidality in Major Depressive Disorder
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COMPLETED
PHASE3
A Study of the Efficacy and Safety of Long-acting Injectable Risperidone and Risperidone Tablets in Patients With Schizophrenia
NCT00240708
COMPLETED
PHASE3
A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia
NCT00236587
COMPLETED
PHASE3
Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia
NCT00821600
COMPLETED
PHASE1
An Open-label Study Evaluating the Maintenance of Clinical Effect in Adult Schizophrenia Patients Switched From Risperidone Tablets to an Equivalent Dose of a Rapidly-dissolving Tablet Formulation of Risperdone
NCT00246272
COMPLETED
PHASE3
Safety and Efficacy of Seroquel in First Episode Schizophrenia
NCT00254241
COMPLETED
PHASE4
An Efficacy and Safety Study of Long-acting Risperidone in Participants With Schizophrenia or Schizoaffective Disorders Who Are Receiving Psychiatric Home Care Treatment
NCT00526877
COMPLETED
PHASE4
Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
NCT00216671
COMPLETED
PHASE4