Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R092670SCA3004 | Other Identifier | Janssen Scientific Affairs, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | paliperidone palmitate 78 117 156 234 mg (50 75 100 or 150 mg eq.) monthly by i.m. injection for 15 months |
|
| 002 | Placebo Comparator | Placebo monthly by i.m. injection for 15 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | monthly by i.m. injection for 15 months |
| |
| paliperidone palmitate |
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind: Percentage of Participants Who Experienced Relapse | 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. | Day 1 up to Month 15 of double blind relapse prevention period |
| Measure | Description | Time Frame |
|---|---|---|
| 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]) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garden Grove | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26934062 | Derived | 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. | |
| 25562685 | Derived | 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. |
Not provided
Not provided
Participants without previous exposure to paliperidone extended-release (ER) (Invega), or risperidone, received paliperidone ER 6 milligram (mg)/day for 4 to 6 days (during Screening) to test oral tolerability. Only participants, who had ability to tolerate the drug, as judged by treating physician, were eligible for enrollment in the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Palmitate | Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. DB Relapse prevention period (15 months): Same dose as Day 92 once every 4 weeks until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Lead in Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months |
|
| Baseline and Week 64 of double blind relapse prevention period |
| Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | 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. | Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | 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. | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores | 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. | Baseline and Endpoint (Week 64/LOCF) in DB period |
| Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | 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. | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | 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. | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | 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. | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | 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. | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint | 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. | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint | 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. | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint | 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". | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint | 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". | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| Oakland |
| California |
| United States |
| Oceanside | California | United States |
| Pico Rivera | California | United States |
| Riverside | California | United States |
| San Diego | California | United States |
| Torrance | California | United States |
| Denver | Colorado | United States |
| Hollywood | Florida | United States |
| Maitland | Florida | United States |
| North Miami | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Marietta | Georgia | United States |
| Schamburg | Illinois | United States |
| Wichita | Kansas | United States |
| Flowood | Mississippi | United States |
| Creve Coeur | Missouri | United States |
| Cedarhurst | New York | United States |
| Staten Island | New York | United States |
| Charlotte | North Carolina | United States |
| Cleveland | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Arlington | Texas | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Irving | Texas | United States |
| San Antonio | Texas | United States |
| Pleven | Bulgaria |
| Plovdiv | Bulgaria |
| Rousse | Bulgaria |
| Sofia | Bulgaria |
| Ahmedabad | India |
| Aurangabad | India |
| Chennai | India |
| Jaipur | India |
| Lucknow Gpo | India |
| Mangalore | India |
| Mysore | India |
| Nashik | India |
| Pune | India |
| Uttar Pradesh | India |
| Vadadora | India |
| Varanasi | India |
| Vijaywada | India |
| Alor Star | Malaysia |
| Ipoh | Malaysia |
| Kota Bharu | Malaysia |
| Kota Kinabalu | Malaysia |
| Kuala Lumpur | Malaysia |
| Tanjong Rambutan | Malaysia |
| Cebu | Philippines |
| Davao City | Philippines |
| Iloilo City | Philippines |
| Quezon City | Philippines |
| Arad | Romania |
| Bucharest | Romania |
| Cluj-Napoca | Romania |
| Craiova | Romania |
| Oradea | Romania |
| Sibiu | Romania |
| Timișoara | Romania |
| Cape Town | South Africa |
| Centurion Gauteng | South Africa |
| Durban | South Africa |
| George | South Africa |
| Johannesburg | South Africa |
| Pretoria | South Africa |
| Tyger Valley | South Africa |
| Dnipropetrovsk | Ukraine |
| Donetsk | Ukraine |
| Hlevakha | Ukraine |
| Ivano-Frankivsk | Ukraine |
| Kharkiv | Ukraine |
| Kiev | Ukraine |
| Poltava | Ukraine |
| Simferopol | Ukraine |
| Uzhhorod | Ukraine |
| Village Stepanovka Kherson | Ukraine |
| Vinnitsa | Ukraine |
| FG001 | Placebo | Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label Stabilization Period |
|
|
| Double Blind Relapse Prevention Period |
|
|
Open-label (OL) intent-to-treat (ITT) analysis set included all participants who received at least 1 injection of open-label study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Included all participants who received at least 1 dose of paliperidone palmitate in open-label lead in period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Double-blind: Percentage of Participants Who Experienced Relapse | 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. | Double-blind(DB) Intent-to-Treat(ITT) analysis set included all randomly assigned participants who received at least 1 injection of DB study medication.'n' signifies participants who were evaluable for each specified category,for each arm. | Posted | Number | percentage of participants | Day 1 up to Month 15 of double blind relapse prevention period |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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]) | 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. | DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and Week 64 of double blind relapse prevention period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | 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. | OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. Last Observation Carried Forward (LOCF) method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | 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. | DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores | 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. | DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values.'n' signifies participants who were evaluable at each specified time point for each arm, respectively. | Posted | Number | participants | Baseline and Endpoint (Week 64/LOCF) in DB period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | 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. | OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | 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. | DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | 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. | OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. n' signifies participants who were evaluable at each specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | 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. | DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint | 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. | OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint | 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. | DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint | 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". | OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint | 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". | DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Endpoint (Week 64/LOCF) in double-blind period |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label - Paliperidone Palmitate | Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. | 54 | 667 | 332 | 667 | ||
| EG001 | Double Blind - Paliperidone Palmitate | DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment. | 9 | 164 | 79 | 164 | ||
| EG002 | Double Blind - Placebo | Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants during DB relapse prevention period. | 16 | 170 | 62 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Block Complete | Cardiac disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Congestive Cardiomyopathy | Cardiac disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Meniere's Disease | Ear and labyrinth disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Brain Contusion | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Multiple Injuries | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Viith Nerve Paralysis | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Depression Suicidal | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Depressive Symptom | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Hallucination, Auditory | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Homicidal Ideation | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Schizoaffective Disorder | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Bladder Prolapse | Renal and urinary disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Therapy Regimen Changed | Surgical and medical procedures | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperprolactinaemia | Endocrine disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Blood Prolactin Increased | Investigations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Glycosylated Haemoglobin Increased | Investigations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Increased Appetite | Metabolism and nutrition disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Schizoaffective Disorder | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
At least 60 days prior to submitting a manuscript the Site shall provide to Sponsor a copy of all such manuscripts and materials,and allow Sponsor 60 days to review and comment on them. If Sponsor requests, the Site shall remove any Confidential Information prior to submitting the materials.The Site agrees that if Study is part of a multi-center study,any publication by the Institution of results of the Study conducted at the Site shall not be made before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Development | Janssen Scientific Affairs, LLC, Titusville, NJ | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Subject Failed Stabilization Criteria |
|
| Other |
|
| Death |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| Withdrawal by Subject |
|
| Experienced Relapse |
|
| > 6 Weeks Between 2 Study Drug |
|
| Adjunct therapy subset (n=86, 97) |
|
| Psychotic Symptoms (n=164, 170) |
|
| Mood Symptoms;Any Mood Symptoms (n=164, 170) |
|
| Mood Symptoms;Manic (n=164, 170) |
|
| Mood Symptoms;Depressive (n=164, 170) |
|
| Mood Symptoms; Mixed (n=164, 170) |
|
| Regression, Cox |
| 0.002 |
| Hazard Ratio (HR) |
| 3.38 |
| 2-Sided |
| 95 |
| 1.57 |
| 7.28 |
| No |
| Superiority or Other |
| Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model. | Regression, Cox | 0.021 | Hazard Ratio (HR) | 2.03 | 2-Sided | 95 | 1.11 | 3.68 | No | Superiority or Other |
| Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model. | Regression, Cox | <0.001 | Hazard Ratio (HR) | 2.82 | 2-Sided | 95 | 1.70 | 4.67 | No | Superiority or Other |
| Mood Symptoms (Any Mood Symptoms):Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model. | Regression, Cox | <0.001 | Hazard Ratio (HR) | 2.93 | 2-Sided | 95 | 1.70 | 5.04 | No | Superiority or Other |
| Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model. | Regression, Cox | 0.012 | Hazard Ratio (HR) | 3.62 | 2-Sided | 95 | 1.32 | 9.89 | No | Superiority or Other |
| Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model. | Regression, Cox | 0.006 | Hazard Ratio (HR) | 3.12 | 2-Sided | 95 | 1.39 | 6.98 | No | Superiority or Other |
| Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model. | Regression, Cox | 0.238 | Hazard Ratio (HR) | 1.93 | 2-Sided | 95 | 0.65 | 5.78 | No | Superiority or Other |
| OG001 | Placebo | Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. |
|
|
|
| OG001 | Placebo | Participants did not receive placebo during open-label lead in period and open-label stabilization period. |
|
|
| OG001 | Placebo | Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. |
|
|
|
| Placebo |
Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. |
|
|
| OG001 | Placebo | Participants did not receive placebo during open-label lead in period and open-label stabilization period. |
|
|
|
|
| OG001 | Placebo | Participants did not receive placebo during open-label lead in period and open-label stabilization period. |
|
|
|
|
| OG001 | Placebo | Participants did not receive placebo during open-label lead in period and open-label stabilization period. |
|
|
| OG001 | Placebo | Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. |
|
|
| OG001 | Placebo | Participants did not receive placebo during open-label lead in period and open-label stabilization period. |
|
|
|
|