Clinical trials
PsiProsper
Identifier
NCT03666715
Link
https://clinicaltrials.gov/study/NCT03666715
Phase
Not provided
Status
Completed
Sponsor
Janssen-Cilag Farmaceutica Ltda.
More details
The purpose of this study is to investigate the mean number of schizophrenia-related hospital admissions, in adult participants with schizophrenia, occurred during 12 months before and 12 months after initiation of Paliperidone Palmitate 1-month formulation treatment.
Purpose
A Study to Analyze the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Participants With Schizophrenia in Portugal
Interventions
Intervention 1
Oral Antipsychotics (OAPs)
Intervention 2
Paliperidone Palmitate 1-Month Formulation (PP1M)
Countries
Portugal
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-08-07
Anticipated Date of Last Follow-up
2025-04-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-05-31
Actual Completion Date
2021-05-31
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
55
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Treatment
Key resources
Not provided
CR108551
Identifier
NCT03713658
Link
https://clinicaltrials.gov/study/NCT03713658
Phase
Marketed
Status
Completed
Sponsor
Janssen Research & Development, LLC
More details
The purpose of this study is to evaluate the feasibility of conducting a study of oral risperidone followed by paliperidone palmitate for once monthly (PP1M) and paliperidone palmitate for every 3 months (PP3M) in rwandan healthcare facilities with mental healthcare capabilities.
Purpose
A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
Interventions
Intervention 1
Risperidone 3 mg
Intervention 2
Paliperidone Palmitate 50 mg eq.
Intervention 3
Paliperidone Palmitate 75 mg eq.
Intervention 4
Paliperidone Palmitate 100 mg eq.
Intervention 5
Paliperidone Palmitate 150 mg eq.
Countries
Rwanda
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-10-18
Anticipated Date of Last Follow-up
2025-04-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-12-02
Actual Completion Date
2019-12-02
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Participants with diagnosis of schizophrenia by mini international neuropsychiatric interview (MINI)- Screen/ MINI (Module K) that requires treatment initiation or a change in treatment to better address safety or efficacy limitations of current treatment
* Participants at least moderately ill as measured by the clinical global impressions - severity of schizophrenia (CGI-SS) scale for schizophrenia, or experiencing poorly tolerated side effects from their current medications, or having difficulty with adequate adherence to treatment, per the investigator's judgement
* Participants have a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition and is expected to be with the participant for gre
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
34
Allocation
Not provided
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Treatment
Key resources
Not provided
SYHF2036-001
Identifier
NCT07268430
Link
https://clinicaltrials.gov/study/NCT07268430
Phase
Not provided
Status
Completed
Sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
More details
This multicenter, randomized, open-label, parallel-group, multiple-dose study is designed to evaluate the bioequivalence, at pharmacokinetic steady state, of a paliperidone palmitate injection manufactured by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (Test Group) and a paliperidone palmitate injection manufactured by Janssen Pharmaceutica N.V. (Reference Group) in patients with schizophrenia in China. Bioequivalence will be assessed based on steady-state pharmacokinetic parameters after repeated intramuscular administration (e.g., Cmax,ss and AUCτ). The safety and tolerability of the test and reference products will also be evaluated.
Purpose
Bioequivalence Study of Long-Acting Paliperidone Palmitate in Patients With Schizophrenia
Interventions
Intervention 1
Paliperidone Palmitate Injection(PP1M)
Intervention 2
Paliperidone Palmitate Injection(PP1M)(Reference Group)
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-12-18
Anticipated Date of Last Follow-up
2025-11-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-12-25
Actual Completion Date
2024-12-25
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Age 18 to 65 years inclusive at the time of consent.
2. Diagnosis of schizophrenia (ICD-10 criteria) prior to screening.
3. PANSS total score ≤70 at screening and at baseline.
4. CGI-S score ≤4 at screening and at baseline.
5. Body weight at screening: ≥50.0 kg (male) or ≥45.0 kg (female); body mass index (BMI) 19.0 to 35.0 kg/m2 (inclusive).
6. The participant and/or partner have no plans for pregnancy during the study and for 6 months after the last dose, and agree to use effective contraception (oral contraceptives are not allowed).
7. Signed informed consent and willingness and ability to comply with all study requirements.
Exclusion Criteria:
1. Known or suspected hypersensitivity to the study drug (paliperidone palmitate) or any of its components.
2. Diagnos
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
256
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Treatment
Key resources
Not provided
CR100662
Identifier
NCT01515423
Link
https://clinicaltrials.gov/study/NCT01515423
Phase
Phase III
Status
Completed
Sponsor
Janssen Research & Development, LLC
More details
The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.
Purpose
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
Interventions
Intervention 1
PP3M 175 mg eq.
Intervention 2
PP3M 263 mg eq.
Intervention 3
PP3M 350 mg eq.
Intervention 4
PP3M 525 mg eq.
Intervention 5
Placebo (20% Intralipid)
Countries
United States of America
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
China
Czechia
France
Germany
Greece
Hungary
Japan
Mexico
Poland
Portugal
Romania
Russian Federation
Slovakia
Spain
Sweden
Taiwan, Province of China
Ukraine
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2012-05-01
Anticipated Date of Last Follow-up
2016-04-28
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2015-02-01
Actual Completion Date
2015-03-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator
* A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120
* Signed informed consent
* Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
* Men must agree to use a double-barrier method of birth control
* Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)
Exclusion Criteria:
* A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, prima
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1429
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Treatment
Key resources
Not provided
100-046
Identifier
NCT04754750
Link
https://clinicaltrials.gov/study/NCT04754750
Phase
Phase I/II
Status
Completed
Sponsor
Calo Psychiatric Center
More details
Schizophrenia is a chronic and severe psychiatric disorder, these patients suffer from positive symptoms, negative symptoms and cognitive deficits, of which working memory problems are considered a central cognitive impairment. Atypical antipsychotics are believed to have a superior effect in reducing both positive and negative symptoms of schizophrenia, coupled with a low risk of extrapyramidal symptoms. Particularly, 2nd-generation antipsychotic medications are commonly used in treatment of schizophrenia. An antipsychotic drug, Paliperidone palmitate (PDP), is administered to patients with schizophrenia as injections at one-month (PP1M) or three-month (PP3M) intervals. This study was compare the effects of treatment, social function, and side effects between PP1M and PP3M in patients wit
Purpose
Differences in Schizophrenia With One-month and 3-month Paliperidone Palmitate Treatment
Interventions
Intervention 1
Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]
Intervention 2
Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-01-01
Anticipated Date of Last Follow-up
2021-02-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2017-06-01
Actual Completion Date
2017-06-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* All of them had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
Exclusion Criteria:
* Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample, as were pregnant and lactating women.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
72
Allocation
Not provided
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Treatment
Key resources
Not provided
CASPAR
Identifier
NCT04940039
Link
https://clinicaltrials.gov/study/NCT04940039
Phase
Marketed
Status
Completed
Sponsor
Janssen-Cilag International NV
More details
The purpose of this study is to assess the long-term symptomatic response (Visit 2 \[Week 1\] to Visit 14/Week 66 \[End of Study {EOS}\]) measured by change in the Clinical Global Impressions -Severity for Schizophrenia (CGI-SS) in participants with schizophrenia who are treated in Rwandan real-world healthcare settings with the antipsychotic regimen that starts with oral anti-psychotic (AP) formulation followed by continued treatment with (paliperidone palmitate 1-month \[PP1M\] and 3-month \[PP3M\] formulations).
Purpose
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Interventions
Intervention 1
Risperidone 3 mg
Intervention 2
Paliperidone Palmitate 50 mg eq.
Intervention 3
Paliperidone Palmitate 75 mg eq.
Intervention 4
Paliperidone Palmitate 100 mg eq.
Intervention 5
Paliperidone Palmitate 150 mg eq.
Countries
Rwanda
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-07-22
Anticipated Date of Last Follow-up
2025-04-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-04-16
Actual Completion Date
2024-04-16
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Diagnosis of schizophrenia by Mini International Neuropsychiatric Interview (MINI)-Screen / MINI (Module K) that requires treatment initiation or a change in treatment to better address safety, efficacy, or adherence limitations of current treatment
* Eligible for treatment in the Rwandan mental healthcare system
* At least moderately ill as measured by the Clinical Global Impression - Severity of Schizophrenia (CGI-SS) scale for schizophrenia (rating of greater than or equal to \[\>=\] 4). This criterion needs to be re-confirmed at Visit 2
* Has a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition, provide economic/cost of care information, and is expected to be with the participant for
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
93
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Treatment
Key resources
Not provided
JiangsuPNBH
Identifier
NCT07075237
Link
https://clinicaltrials.gov/study/NCT07075237
Phase
Marketed
Status
Not yet recruiting
Sponsor
Jiangsu Province Nanjing Brain Hospital
More details
To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function
Purpose
Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia
Interventions
Intervention 1
Paliperidone Palmitate Injection (PP1M)
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-10-01
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-09-24
Estimated Primary Completion Date
2026-10-01
Estimated Completion Date
2027-03-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Outpatients or inpatients meeting DSM-5 diagnostic criteria forschizophrenia;
2. Aged 18-65 years (inclusive), regardless of gender;
3. Currently receiving first- or second-generation oral antipsychotics (excluding clozapine) with stable condition as assessed by the investigator, and PANSS total score ≤80 at screening and baseline;
4. Signed informed consent by the patient and/or guardian;
Exclusion Criteria:
1. Comorbid psychiatric diagnoses other than schizophrenia;
2. Severe physical diseases, intellectual disability, organic brain disorders, or mental disorders due to physical illnesses;
3. QTc interval \>450 ms (male) or \>460 ms (female);
4. History of psychoactive substance abuse (excluding tobacco) within the past 12 months, or significant suicidal/violent
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
120
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Treatment
Key resources
Not provided
DREaM
Identifier
NCT02431702
Link
https://clinicaltrials.gov/study/NCT02431702
Phase
Phase III
Status
Completed
Sponsor
Janssen Scientific Affairs, LLC
More details
The purpose of the study is to compare effectiveness of paliperidone palmitate (PP: paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP \[that is oral paliperidone extended release {ER}, oral risperidone, or another OAP\]) in delaying time to treatment failure. The study will also evaluate changes in cognition, functioning, brain intracortical myelin (ICM) volume following treatment with PP compared with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.
Purpose
A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or
Interventions
Intervention 1
Aripiprazole
Intervention 2
Haloperidol
Intervention 3
Olanzapine
Intervention 4
Oral Paliperidone ER
Intervention 5
Perphenazine
Countries
United States of America
Brazil
Mexico
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-07-08
Anticipated Date of Last Follow-up
2025-04-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-11-12
Actual Completion Date
2019-11-12
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Participant must have a current diagnosis of schizophrenia (295.90) or schizophreniform disorder (295.40) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and confirmed by the Structured Clinical Interview for DSM-5 Disorders (SCID) with a first psychotic episode within the last 24 months prior to the screening visit
* Participant requires treatment with an antipsychotic medication
* Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
* Participant must have available a designated individual (example, family member, significant other, friend) who has knowledge of the participant and is generall
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
337
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intramuscular
Use case
Treatment
Key resources
Not provided
