Trial · NCT01193153
A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
NCT01193153, Phase 3, Completed, Janssen Scientific Affairs, LLC; results first posted 2015-01-05
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ConductScience Library. A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder. Trials, record NCT01193153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01193153
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
- NCT number
- NCT01193153
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 667 participants, actual
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Conditions
- Schizoaffective Disorder
- Interventions
- Placebo, paliperidone palmitate
- First posted
- 2010-09-01
- Last updated
- 2015-01-05
- Results first posted
- 2015-01-05
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind: Percentage of Participants Who Experienced Relapse | Day 1 up to Month 15 of double blind relapse prevention period | 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. |
| 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]) | Baseline and Week 64 of double blind relapse prevention period | 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. |
| Secondary | Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | 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. |
| Secondary | Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | Baseline and Endpoint (Week 64/LOCF) in double-blind period | 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. |
| Secondary | Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores | Baseline and Endpoint (Week 64/LOCF) in DB period | 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. |
| Secondary | Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | 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. |
| Secondary | Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | Baseline and Endpoint (Week 64/LOCF) in double-blind period | 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. |
| Secondary | Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | 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. |
| Secondary | Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | Baseline and Endpoint (Week 64/LOCF) in double-blind period | 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. |
| Secondary | Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-blind: Percentage of Participants Who Experienced Relapse | Day 1 up to Month 15 of double blind relapse prevention period | 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. | percentage of participants | NUMBER |
| 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]) | Baseline and Week 64 of double blind relapse prevention period | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | 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. | Units on a Scale | MEAN |
| SECONDARY | Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint | Baseline and Endpoint (Week 64/LOCF) in double-blind period | 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. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores | Baseline and Endpoint (Week 64/LOCF) in DB period | 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. | participants | NUMBER |
| SECONDARY | Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | 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. | Units on a scale | MEAN |
| SECONDARY | Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint | Baseline and Endpoint (Week 64/LOCF) in double-blind period | 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. | Units on a scale | MEAN |
| SECONDARY | Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | 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. | Units on a scale | MEAN |
| SECONDARY | Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint | Baseline and Endpoint (Week 64/LOCF) in double-blind period | 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. | Units on a scale | MEAN |
| SECONDARY | Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint | Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period | 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. | Units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group67
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-blind: Percentage of Participants Who Experienced Relapse | Paliperidone Palmitate | All Participants (n=164, 170) | 15.2 | NA to NA | percentage of participants |
| Double-blind: Percentage of Participants Who Experienced Relapse | Placebo | All Participants (n=164, 170) | 33.5 | NA to NA | percentage of participants |
| Double-blind: Percentage of Participants Who Experienced Relapse | Paliperidone Palmitate | Monotherapy subset (n=78, 73) | 11.5 | percentage of participants | |
| Double-blind: Percentage of Participants Who Experienced Relapse | Placebo | Monotherapy subset (n=78, 73) | 32.9 | percentage of participants | |
| Double-blind: Percentage of Participants Who Experienced Relapse | Paliperidone Palmitate | Adjunct therapy subset (n=86, 97) | 18.6 | percentage of participants | |
| Double-blind: Percentage of Participants Who Experienced Relapse | Placebo | Adjunct therapy subset (n=86, 97) | 34.0 | percentage of participants | |
| Double-blind: Percentage of Participants Who Experienced Relapse | Paliperidone Palmitate | Psychotic Symptoms (n=164, 170) | 12.8 | percentage of participants | |
| Double-blind: Percentage of Participants Who Experienced Relapse | Placebo | Psychotic Symptoms (n=164, 170) | 31.2 | percentage of participants | |
| Double-blind: Percentage of Participants Who Experienced Relapse | Paliperidone Palmitate | Mood Symptoms;Any Mood Symptoms (n=164, 170) | 11.0 | percentage of participants | |
| Double-blind: Percentage of Participants Who Experienced Relapse | Placebo | Mood Symptoms;Any Mood Symptoms (n=164, 170) | 28.2 | percentage of participants |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Lead in Period | STARTED | Paliperidone Palmitate | 667 | |
| Open-label Lead in Period | STARTED | Placebo | 0 | |
| Open-label Lead in Period | COMPLETED | Paliperidone Palmitate | 432 | |
| Open-label Lead in Period | COMPLETED | Placebo | 0 | |
| Open-label Lead in Period | NOT COMPLETED | Paliperidone Palmitate | 235 | |
| Open-label Lead in Period | NOT COMPLETED | Placebo | 0 | |
| Open-label Stabilization Period | STARTED | Paliperidone Palmitate | 432 | |
| Open-label Stabilization Period | STARTED | Placebo | 0 | |
| Open-label Stabilization Period | COMPLETED | Paliperidone Palmitate | 334 | |
| Open-label Stabilization Period | COMPLETED | Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events210
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperprolactinaemia | Endocrine disorders | Open Label - Paliperidone Palmitate | 9 | 667 | |
| other | Hyperprolactinaemia | Endocrine disorders | Double Blind - Paliperidone Palmitate | 7 | 164 | |
| other | Hyperprolactinaemia | Endocrine disorders | Double Blind - Placebo | 2 | 170 | |
| other | Constipation | Gastrointestinal disorders | Open Label - Paliperidone Palmitate | 14 | 667 | |
| other | Constipation | Gastrointestinal disorders | Double Blind - Paliperidone Palmitate | 2 | 164 | |
| other | Constipation | Gastrointestinal disorders | Double Blind - Placebo | 0 | 170 | |
| other | Diarrhoea | Gastrointestinal disorders | Open Label - Paliperidone Palmitate | 20 | 667 | |
| other | Diarrhoea | Gastrointestinal disorders | Double Blind - Paliperidone Palmitate | 4 | 164 | |
| other | Diarrhoea | Gastrointestinal disorders | Double Blind - Placebo | 2 | 170 | |
| other | Dry Mouth | Gastrointestinal disorders | Open Label - Paliperidone Palmitate | 15 | 667 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label - Paliperidone Palmitate | ||
| Total, all-cause mortality | Double Blind - Paliperidone Palmitate | ||
| Total, all-cause mortality | Double Blind - Placebo | ||
| Total, other adverse events | Open Label - Paliperidone Palmitate | 332 | 667 |
| Total, other adverse events | Double Blind - Paliperidone Palmitate | 79 | 164 |
| Total, other adverse events | Double Blind - Placebo | 62 | 170 |
| Total, serious adverse events | Open Label - Paliperidone Palmitate | 54 | 667 |
| Total, serious adverse events | Double Blind - Paliperidone Palmitate | 9 | 164 |
| Total, serious adverse events | Double Blind - Placebo | 16 | 170 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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