A Phase 3 interventional study of Asenapine - Open Label and Placebo - Double Blind in Schizophrenia, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 831 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: Asenapine - Open Label · Drug: Asenapine - Double Blind
Drug: Asenapine - Open Label · Drug: Placebo - Double Blind
Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).
Also known as: Saphris, Org 5222, SCH 900274
Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.
Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.
Also known as: Org 5222, SCH 900274, Saphris
Time to Relapse or an Impending Relapse
A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.
Time frame: time of first relapse up to Day 182 (double blind phase)
Time to Early Discontinuation for Any Reason
The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).
Time frame: time of discontinuation up to Day 182 (double blind phase)
| Milestone | Asenapine | Placebo |
|---|---|---|
| Started | 194 | 192 |
| Completed | 135 | 72 |
| Not completed | 59 | 120 |
| Withdrew: Adverse event | 16 | 53 |
| Withdrew: Relapse/impending relapse, non-ae | 10 | 39 |
| Withdrew: Withdrawal by subject | 19 | 12 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Withdrew: Other | 11 | 13 |
A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.
| relapses | Asenapine | Placebo |
|---|---|---|
| Days 1 - 7 (N asenapine = 190; N placebo = 190) | 0 | 3 |
| Days 8 - 14 (N asenapine = 188; N placebo = 186) | 1 | 14 |
| Days 15 - 21 (N asenapine = 183; N placebo = 170) | 2 | 9 |
| Days 22 - 28 (N asenapine = 180; N placebo = 160) | 2 | 8 |
| Days 29 - 35 (N asenapine = 175; N placebo = 149) | 0 | 7 |
| Days 36 - 42 (N asenapine = 175; N placebo = 140) | 1 | 8 |
| Days 43 - 49 (N asenapine = 173; N placebo = 130) | 5 | 2 |
| Days 50 - 56 (N asenapine = 166; N placebo = 127) | 1 | 4 |
| Days 57 - 63 (N asenapine = 165; N placebo = 123) | 1 | 1 |
| Days 64 - 70 (N asenapine = 163; N placebo = 120) | 2 | 3 |
| Days 71 - 77 (N asenapine = 161; N placebo = 117) | 1 | 4 |
| Days 78 - 84 (N asenapine = 160; N placebo = 113) | 2 | 2 |
| Days 85 - 91 (N asenapine = 158; N placebo = 110) | 0 | 4 |
| Days 92 - 98 (N asenapine = 154; N placebo = 104) | 0 | 4 |
| Days 99 - 105 (N asenapine = 151; N placebo = 99) | 0 | 2 |
| Days 106 - 112 (N asenapine = 151; N placebo = 96) | 0 | 1 |
| Days 113 - 119 (N asenapine = 149; N placebo = 95) | 2 | 3 |
| Days 120 - 126 (N asenapine = 147; N placebo = 87) | 0 | 1 |
| Days 127 - 133 (N asenapine = 147; N placebo = 86) | 0 | 1 |
| Days 134 - 140 (N asenapine = 146; N placebo = 84) | 0 | 0 |
| Days 141 - 147 (N asenapine = 145; N placebo = 83) | 0 | 1 |
| Days 148 - 154 (N asenapine = 142; N placebo = 81) | 0 | 5 |
| Days 155 - 161 (N asenapine = 141; N placebo = 75) | 0 | 1 |
| Days 162 - 168 (N asenapine = 139; N placebo = 74) | 1 | 0 |
| Days 169 - 175 (N asenapine = 137; N placebo = 72) | 2 | 1 |
| Days 176 - 182 (N asenapine = 135; N placebo = 70) | 0 | 1 |
| Days 183 - 189 (N asenapine = 75; N placebo = 39) | 0 | 0 |
| Days 190 - 196 (N asenapine = 9; N placebo = 9) | 0 | 0 |
| Days 197 - 203 (N asenapine = 2; N placebo = 2) | 0 | 0 |
| Days 204 - 210 (N asenapine = 0; N placebo = 1) | 0 | 0 |
The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).
| participants | Asenapine | Placebo |
|---|---|---|
| Days 1 - 7 (N asenapine = 191; N placebo = 191) | 1 | 2 |
| Days 8 - 14 (N asenapine = 190; N placebo = 189) | 6 | 14 |
| Days 15 - 21 (N asenapine = 184; N placebo = 175) | 3 | 10 |
| Days 22 - 28 (N asenapine = 181; N placebo = 165) | 5 | 11 |
| Days 29 - 35 (N asenapine = 176; N placebo = 154) | 0 | 11 |
| Days 36 - 42 (N asenapine = 176; N placebo = 143) | 3 | 7 |
| Days 43 - 49 (N asenapine = 173; N placebo = 136) | 7 | 7 |
| Days 50 - 56 (N asenapine = 166; N placebo = 129) | 0 | 3 |
| Days 57 - 63 (N asenapine = 166; N placebo = 126) | 3 | 4 |
| Days 64 - 70 (N asenapine = 163; N placebo = 122) | 1 | 2 |
| Days 71 - 77 (N asenapine = 162; N placebo = 120) | 0 | 4 |
| Days 78 - 84 (N asenapine = 162; N placebo = 116) | 4 | 3 |
| Days 85 - 91 (N asenapine = 158; N placebo = 113) | 5 | 8 |
| Days 92 - 98 (N asenapine = 153; N placebo = 105) | 2 | 4 |
| Days 99 - 105 (N asenapine = 150; N placebo = 100) | 0 | 2 |
| Days 106 - 112 (N asenapine = 150; N placebo = 98) | 1 | 1 |
| Days 113 - 119 (N asenapine = 149; N placebo = 97) | 1 | 8 |
| Days 120 - 126 (N asenapine = 148; N placebo = 88) | 0 | 1 |
| Days 127 - 133 (N asenapine = 148; N placebo = 87) | 2 | 0 |
| Days 134 - 140 (N asenapine = 146; N placebo = 86) | 0 | 1 |
| Days 141 - 147 (N asenapine = 145; N placebo = 84) | 3 | 1 |
| Days 148 - 154 (N asenapine = 142; N placebo = 82) | 1 | 3 |
| Days 155 - 161 (N asenapine = 141; N placebo = 78) | 1 | 3 |
| Days 162 - 168 (N asenapine = 139; N placebo = 75) | 2 | 1 |
| Days 169 - 175 (N asenapine = 137; N placebo = 73) | 2 | 1 |
| Days 176 - 182 (N asenapine = 135; N placebo = 71) | 0 | 1 |
| Days 183 - 189 (N asenapine = 75; N placebo = 39) | 0 | 0 |
| Days 190 - 196 (N asenapine = 9; N placebo = 9) | 0 | 0 |
| Days 197 - 203 (N asenapine = 2; N placebo = 2) | 0 | 0 |
| Days 204 - 210 (N asenapine = 0; N placebo = 1) | 0 | 0 |
Collected over Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asenapine | — | 6/194 (3.1%) | 121/194 (62.4%) |
| Placebo | — | 22/192 (11.5%) | 127/192 (66.1%) |
| Asenapine During Open-Label Phase and Not Randomized | — | 39/314 (12.4%) | 170/314 (54.1%) |
| Event | Asenapine | Placebo | Asenapine During Open-Label Phase and Not Randomized |
|---|---|---|---|
| SCHIZOPHRENIAPsychiatric disorders | 2/194 | 9/192 | 10/314 |
| SCHIZOPHRENIA, PARANOID TYPEPsychiatric disorders | 2/194 | 7/192 | 11/314 |
| BRONCHITISInfections and infestations | 0/194 | 0/192 | 2/314 |
| PNEUMONIAInfections and infestations | 0/194 | 0/192 | 2/314 |
| AGITATIONPsychiatric disorders | 0/194 | 0/192 | 2/314 |
| PSYCHOTIC DISORDERPsychiatric disorders | 0/194 | 0/192 | 2/314 |
| HYPOTHERMIAGeneral disorders | 0/194 | 1/192 | 0/314 |
| ADNEXITISInfections and infestations | 0/194 | 1/192 | 0/314 |
| GASTROENTERITISInfections and infestations | 0/194 | 1/192 | 0/314 |
| BLOOD GLUCOSE DECREASEDInvestigations | 0/194 | 1/192 | 0/314 |
| Event | Asenapine | Placebo | Asenapine During Open-Label Phase and Not Randomized |
|---|---|---|---|
| INSOMNIAPsychiatric disorders | 39/194 | 47/192 | 42/314 |
| SOMNOLENCENervous system disorders | 31/194 | 33/192 | 54/314 |
| WEIGHT INCREASEDInvestigations | 28/194 | 21/192 | 11/314 |
| ANXIETYPsychiatric disorders | 25/194 | 27/192 | 34/314 |
| SCHIZOPHRENIAPsychiatric disorders | 8/194 | 25/192 | 8/314 |
| WEIGHT DECREASEDInvestigations | 13/194 | 21/192 | 3/314 |
| HEADACHENervous system disorders | 21/194 | 19/192 | 19/314 |
| AGITATIONPsychiatric disorders | 12/194 | 19/192 | 24/314 |
| AKATHISIANervous system disorders | 13/194 | 13/192 | 21/314 |
| HALLUCINATIONPsychiatric disorders | 2/194 | 13/192 | 6/314 |
| Age, Continuous(years) | Asenapine | Placebo | Total |
|---|---|---|---|
| Mean | 39.2 ± 12.53 | 38.7 ± 11.64 | 38.9 ± 12.08 |
| Sex: Female, Male(Participants) | Asenapine | Placebo | Total |
|---|---|---|---|
| Female | 89 | 76 | 165 |
| Male | 105 | 116 | 221 |
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