Adults 12 to 17, any sex, with Schizophrenia, Paranoid or Schizophrenia, Disorganized. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56Primary· Baseline and Day 56
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assi
Group
Value
95% CI
Placebo
-17.8
-20.7 – -13.5
Asenapine 2.5 mg BID
-23.7
-25.5 – -18.2
Asenapine 5.0 mg BID
-25.5
-26.3 – -19.1
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56Secondary· Baseline and Day 56
Change from baseline in CGI-S score at Day 56 is the Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Group
Value
95% CI
Placebo
-0.8
-1.0 – -0.6
Asenapine 2.5 mg BID
-1.1
-1.2 – -0.8
Asenapine 5.0 mg BID
-1.3
-1.4 – -1.0
Change From Baseline in PANSS Positive Subscale Score at Day 56Secondary· Baseline and Day 56
This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measu
Group
Value
95% CI
Placebo
-6.0
-7.1 – -4.7
Asenapine 2.5 mg BID
-7.9
-8.7 – -6.3
Asenapine 5.0 mg BID
-9.1
-9.3 – -6.9
Change From Baseline in PANSS Negative Subscale Score at Day 56Secondary· Baseline and Day 56
This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS negative subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported
Group
Value
95% CI
Placebo
-3.4
-4.3 – -2.3
Asenapine 2.5 mg BID
-4.8
-5.5 – -3.5
Asenapine 5.0 mg BID
-4.9
-5.5 – -3.5
Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56Secondary· Baseline and Day 56
This measure reports results for the combined positive subscale (7 items) and negative subscale (7 items) of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each of the total 14 items in the combined positive and negative subscales, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive and negative subscale
Group
Value
95% CI
Placebo
-9.4
-11.2 – -7.2
Asenapine 2.5 mg BID
-12.7
-14.0 – -9.9
Asenapine 5.0 mg BID
-14.0
-14.4 – -10.5
Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56Secondary· Baseline and Day 56
This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in sym
Group
Value
95% CI
Placebo
-8.5
-9.7 – -6.2
Asenapine 2.5 mg BID
-10.9
-11.9 – -8.3
Asenapine 5.0 mg BID
-11.5
-12.0 – -8.5
Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56Secondary· Baseline and Day 56
This measure reports results for the 8 items of the Marder positive symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items (Marder et al. J Clin Psychiatry 1997;58(12):538-46). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder positive symptoms factor score for each participant was calculated as the sum of the rating as
Group
Value
95% CI
Placebo
-6.1
-7.3 – -4.9
Asenapine 2.5 mg BID
-7.9
-8.7 – -6.2
Asenapine 5.0 mg BID
-8.9
-9.2 – -6.8
Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56Secondary· Baseline and Day 56
This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder negative symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor
Group
Value
95% CI
Placebo
-3.7
-4.6 – -2.6
Asenapine 2.5 mg BID
-5.2
-5.9 – -3.9
Asenapine 5.0 mg BID
-5.3
-5.9 – -3.9
Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56Secondary· Baseline and Day 56
This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder disorganized thoughts factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms
Group
Value
95% CI
Placebo
-3.4
-4.3 – -2.6
Asenapine 2.5 mg BID
-4.3
-5.2 – -3.5
Asenapine 5.0 mg BID
-4.8
-5.2 – -3.5
Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56Secondary· Baseline and Day 56
This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder hostility/excitement factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.
Group
Value
95% CI
Placebo
-2.8
-3.3 – -1.8
Asenapine 2.5 mg BID
-3.8
-4.3 – -2.8
Asenapine 5.0 mg BID
-3.8
-4.1 – -2.6
Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56Secondary· Baseline and Day 56
This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder anxiety/depression factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The
Group
Value
95% CI
Placebo
-1.8
-2.3 – -1.2
Asenapine 2.5 mg BID
-2.4
-2.7 – -1.6
Asenapine 5.0 mg BID
-2.7
-2.8 – -1.8
Total PANSS 30% RespondersSecondary· Baseline up to Day 56
A Total PANSS 30% responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS Total score at the last available assessment of the study for that participant (i.e., endpoint). The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms.
Group
Value
95% CI
Placebo
36
Asenapine 2.5 mg BID
48
Asenapine 5.0 mg BID
51
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 30 days after the last dose of study drug.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in adolescents with schizophrenia. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily \[BID\]) or placebo for 8 weeks. Throughout the study, observations will be made on each participant at various times to assess the efficacy and safety of the study treatment. The primary objective of the trial is to demonstrate significant superiority of at least one asenapine dose to placebo, as measured by the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 21 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01190254.