- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01193153
A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
December 22, 2014 updated by: Janssen Scientific Affairs, LLC
A Randomized, Double-Blind, Placebo-Controlled, Parellel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder
This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder.
This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Schizoaffective disorder is a chronic illness and generally requires life-long treatment.
To date however, no medication has been evaluated in the maintenance treatment of schizoaffective disorder.
This is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of paliperidone palmitate, as monotherapy or as an adjunct to mood stabilizers or antidepressants, relative to placebo in delaying the time to relapse in patients with schizoaffective disorder.
This study explores the use of paliperidone palmitate either as monotherapy or as an adjunct to mood stabilizers or antidepressants (MS/AD) because both treatment approaches are commonly used in the clinical management of schizoaffective disorder.
Patients with acute symptoms of schizoaffective disorder will be enrolled.
The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 13-week open-label flexible dose lead-in period, a 12-week open-label fixed dose stabilization period, and a 15 months double-blind relapse prevention period.
Patients without previous exposure to paliperidone ER (Invega), paliperidone palmitate (Invega Sustenna), risperidone, or RISPERDAL CONSTA will be given 4 to 6 days of paliperidone ER 6mg/day for tolerability testing.
Patients can continue their current antipsychotic regimen through Day -1 (the day before the start of the study period).
During the open-label periods, all patients will be treated with paliperidone palmitate.
An initial loading dose of 234 mg (150 mg eq.) of paliperidone palmitate will be given by deltoid injection followed by 156 mg (100 mg eq.) deltoid injection on Day 8. Starting on Day 36, injections may be administered in either the deltoid muscle or the gluteal muscle.
Doses at Days 36, 64 and 92 may be increased or decreased within the range of 78 mg (50 mg eq.) and 234 mg (150 mg.
eq.) as clinically indicated.
Dose will be fixed (at Day 92 dose) during the 12-week stabilization period.
Patients who meet pre-determined stabilization criteria will be eligible to enter the double-blind relapse prevention period and will be randomly assigned to either receive paliperidone palmitate (at the Day 92 dose) or placebo treatment.
Patients will have intramuscular (i.m.) study drug injection and efficay and saftety evaluations performed every 4 weeks throughout the study.
Efficacy will be evaluated during the study using a relapse assessment, the Positive and Negative Symptom Scale (PANSS), the Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA), the Personal and Social Performance Scale (PSP), the Young Mania Rating Scale (YMRS), and the Hamilton Rating Scale for Depression (HAM-D).
Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements (temperature, pulse, and blood pressure), weight, and the monitoring of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A).
Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study.
Participation in pharmacogenomic research is optional.
Blood samples will be taken from patients being treated with lithium or valproate for the measurement of blood lithium or valproate levels.
Approximately 52 mL (31 mL for patients who are not receiving lithium or valproate) of whole blood will be collected during the study.
All patients will receive paliperidone palmitate 78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for the the first 25 weeks of the study (open-label periods).
During the 15-month double-blind relapse prevention period, one half of the patients will be randomized to paliperidone palmitate treatment (50, 75, 100, or 150 mg eq.
monthly i.m. injection) and the other half of the patients will be randomized to monthly placebo injection.
Study Type
Interventional
Enrollment (Actual)
667
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pleven, Bulgaria
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Plovdiv N/A, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Ahmedabad, India
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Aurangabad, India
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Chennai, India
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Jaipur, India
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Lucknow Gpo, India
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Mangalore, India
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Mysore, India
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Nasik, India
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Pune, India
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Uttar Pradesh, India
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Vadadora, India
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Varanasi, India
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Vijaywada, India
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Alor Setar, Malaysia
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Ipoh, Malaysia
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Kota Bharu, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Kuala Lumpur N/A, Malaysia
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Tanjong Rambutan, Malaysia
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Cebu, Philippines
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Davao City, Philippines
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Iloilo, Philippines
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Iloilo City, Philippines
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Quezon City, Philippines
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Arad, Romania
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Bucharest, Romania
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Bucuresti, Romania
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Cluj, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Oradea, Romania
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Sibiu, Romania
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Timisoara, Romania
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Cape Town, South Africa
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Centurion Gauteng, South Africa
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Durban, South Africa
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George, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Tyger Valley, South Africa
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Glevakha, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkov, Ukraine
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Kiev, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Uzhgorod, Ukraine
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Village Stepanovka Kherson, Ukraine
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Vinnitsa, Ukraine
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California
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Garden Grove, California, United States
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Oakland, California, United States
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Oceanside, California, United States
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Pico Rivera, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Colorado
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Denver, Colorado, United States
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Florida
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Hollywood, Florida, United States
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Maitland, Florida, United States
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North Miami, Florida, United States
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Tampa, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Illinois
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Schamburg, Illinois, United States
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Kansas
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Wichita, Kansas, United States
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Mississippi
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Flowood, Mississippi, United States
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Missouri
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Creve Coeur, Missouri, United States
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New York
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Cedarhurst, New York, United States
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Staten Island, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Ohio
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Cleveland, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Texas
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- DSM-IV diagnosis of schizoaffective disorder
- Experiencing an acute exacerbation of psychotic symptoms
- A score of >=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
- A score of >=16 on YMRS and/or a score of >=16 on the HAM-D-21
- Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
Exclusion Criteria:
- A primary active mental illness diagnosis other than schizoaffective disorder
- Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior
- Subjects with first episode of psychosis
- Received electroconvulsive therapy in the past 3 months
- History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)
- Received long-acting antipsychotic medication within 2 injection cycles
- Received therapy with clozapine within 3 months
- A history of neuroleptic malignant syndrome
- Previous history of lack of response to antipsychotic medication
- Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening
- Receiving therapy with carbamazepine
- Receiving therapy with monoamine oxidase inhibitors
- Pregnant, breast-feeding, or planning to become pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 001
paliperidone palmitate 78 117 156 234 mg (50 75 100 or 150 mg eq.) monthly by i.m. injection for 15 months
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78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months
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Placebo Comparator: 002
Placebo monthly by i.m. injection for 15 months
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monthly by i.m. injection for 15 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Double-blind: Percentage of Participants Who Experienced Relapse
Time Frame: Day 1 up to Month 15 of double blind relapse prevention period
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Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (>= 6) after randomization(if the score for the corresponding item was less than or equal to [<=] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits.
Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined.
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Day 1 up to Month 15 of double blind relapse prevention period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])
Time Frame: Baseline and Week 64 of double blind relapse prevention period
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The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe).
Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning.
A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.
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Baseline and Week 64 of double blind relapse prevention period
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Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
Time Frame: Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe).
Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning.
A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.
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Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period
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The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe).
Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning.
A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.
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Baseline and Endpoint (Week 64/LOCF) in double-blind period
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Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores
Time Frame: Baseline and Endpoint (Week 64/LOCF) in DB period
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The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe).
Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning.
Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed.
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Baseline and Endpoint (Week 64/LOCF) in DB period
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Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
Time Frame: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control.
The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210.
Higher scores indicate worsening.
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Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period
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The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control.
The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210.
Higher scores indicate worsening.
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Baseline and Endpoint (Week 64/LOCF) in double-blind period
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Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
Time Frame: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression.
The items are rated on a 5-point (0 to 4) scale.
The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe).
A rating of 4 is usually reserved for extreme symptoms.
The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.
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Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period
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The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression.
The items are rated on a 5-point (0 to 4) scale.
The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe).
A rating of 4 is usually reserved for extreme symptoms.
The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.
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Baseline and Endpoint (Week 64/LOCF) in double-blind period
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Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint
Time Frame: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence).
YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4).
Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8).
The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter.
Higher scores indicate worsening.
Responses are summed to yield YMRS total score ranging from 0 to 60.
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Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint
Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period
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The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence).
YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4).
Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8).
The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter.
Higher scores indicate worsening.
Responses are summed to yield YMRS total score ranging from 0 to 60.
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Baseline and Endpoint (Week 64/LOCF) in double-blind period
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Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint
Time Frame: Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness.
The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit".
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Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
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Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint
Time Frame: Baseline and Endpoint (Week 64/LOCF) in double-blind period
|
The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness.
The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit".
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Baseline and Endpoint (Week 64/LOCF) in double-blind period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Alphs L, Fu DJ, Turkoz I. Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother. 2016;17(6):871-83. doi: 10.1517/14656566.2016.1161029. Epub 2016 Mar 24.
- Fu DJ, Turkoz I, Simonson RB, Walling DP, Schooler NR, Lindenmayer JP, Canuso CM, Alphs L. Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder. J Clin Psychiatry. 2015 Mar;76(3):253-62. doi: 10.4088/JCP.14m09416.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
August 30, 2010
First Submitted That Met QC Criteria
August 30, 2010
First Posted (Estimate)
September 1, 2010
Study Record Updates
Last Update Posted (Estimate)
January 5, 2015
Last Update Submitted That Met QC Criteria
December 22, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Disease Attributes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Disease
- Psychotic Disorders
- Recurrence
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID Numbers
- CR016618
- R092670SCA3004 (Other Identifier: Janssen Scientific Affairs, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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