Schizophrenia, ParanoidPhase 3NCT01190254

Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)

A Phase 3 study testing asenapine 2.5 mg and asenapine 5.0 mg in people with Schizophrenia, Paranoid and Schizophrenia, Disorganized, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Schizophrenia, Paranoid, Schizophrenia, Disorganized, Schizophrenia, Undifferentiated
What is being tested?: asenapine 2.5 mg and asenapine 5.0 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 306 participants
Where: No sites listed yet
Study dates: 28 Sep 2010to 1 Apr 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Each participant must have schizophrenia, diagnosed and confirmed by board-eligible or board certified psychiatrists with at least two years of specialization in pediatric/adolescent psychiatric medicine.
Each participant must be ≥12 years of age and <18 years of age.
Each participant must have a minimum PANSS total score of 80 at Screening and Baseline.
Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution) at Screening and Baseline.
Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline.
Each participant must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers) prior to Baseline.
Each participant must agree not to begin formal, structured psychotherapy during the trial.

Who cannot join

A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with "continuous," "single episode in partial remission," or "single episode in full remission" course specifiers.
A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.
A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder.
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria for substance abuse or dependence (excluding nicotine).
A participant must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse.
A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).

About this study

Official title: An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

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.

Conditions: Schizophrenia, Paranoid, Schizophrenia, Disorganized, Schizophrenia, Undifferentiated
Being tested: asenapine 2.5 mg, asenapine 5.0 mg, placebo
Keywords: Asenapine, adolescents, schizophrenia, phase IIIb, placebo-controlled
Medical subject headings: Schizophrenia, Paranoid, Schizophrenia, Disorganized, Schizophrenia, Disorders of Sex Development

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

asenapine 2.5 mgDrug
Also called Saphris®, SCH 900274, Org 5222
asenapine 2.5 mg tablets for sublingual administration
asenapine 5.0 mgDrug
Also called Saphris®, SCH 900274, Org 5222
asenapine 5.0 mg tablets for sublingual administration
placeboDrug
asenapine-matched placebo tablets for sublingual administration

Study groups in NCT01190254
Study group	Role	What they receive
Asenapine 2.5 mg BID	Experimental	Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks. Receives: Drug: asenapine 2.5 mg
Asenapine 5.0 mg BID	Experimental	Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period. Receives: Drug: asenapine 2.5 mg; Drug: asenapine 5.0 mg
Placebo	Placebo comparator	Participants receive placebo asenapine tablets sublingually BID for 8 weeks. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 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 assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56

Secondary outcomes (18)

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 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.
Measured: Baseline and Day 56
Change From Baseline in PANSS Positive Subscale Score at 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 measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56
Change From Baseline in PANSS Negative Subscale Score at 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 measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56
Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at 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 scores combined for each participant was calculated as the sum of the rating assigned to each of the 14 combined subscale items, and ranged from 14 to 98 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56
Change From Baseline in PANSS General Psychopathology Subscale Score at 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 symptoms is represented by negative values.
Measured: Baseline and Day 56
Change From Baseline in PANSS Marder Positive Symptoms Factor Score at 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 assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56
Change From Baseline in PANSS Marder Negative Symptoms Factor Score at 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 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56
Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56
Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56
Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at 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 reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
Measured: Baseline and Day 56
Total PANSS 30% Responders
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.
Measured: Baseline up to Day 56
Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study
A total PANSS 30% response was defined as a reduction from baseline of at least 30% in the PANSS Total score. 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. The Kaplan-Meier estimate reports the cumulative percentage of participants with total PANSS 30% response from first drug intake up to approximately Day 59.
Measured: Baseline up to approximately Day 59
Clinical Global Impression of Improvement (CGI-I) Score at Day 56
CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.
Measured: Baseline and Day 56
CGI-I Responders
A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at the last available assessment of the study for that participant (i.e., endpoint). CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.
Measured: Baseline up to Day 56
Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study
CGI-I response was defined as the occurrence of a CGI-I score of 1 (very much improved) or 2 (much improved). CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. The Kaplan-Meier estimate reports the cumulative percentage of participants with CGI-I response from first drug intake up to approximately Day 58.
Measured: Baseline up to approximately Day 58
Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56
CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 56; improvement in functioning is represented by positive values.
Measured: Baseline and Day 56
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56
PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used a last-observation-carried-forward (LOCF) approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.
Measured: Baseline and Day 56
Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56
PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.
Measured: Baseline and Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 20101 Apr 2013

First posted27 Aug 2010 (estimated)
Study start28 Sep 2010
Primary completion10 Mar 2013
Study completion1 Apr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Schizophrenia, ParanoidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01190254
Sponsor's protocol ID: P05896
Other IDs: 2009-017971-10, MK-8274-020, CTRI/2011/07/001909, 2009
Status last verified: Feb 2022
First submitted: 25 Aug 2010
Last updated: 21 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Findling RL, Landbloom RP, Mackle M, Pallozzi W, Braat S, Hundt C, Wamboldt MZ, Mathews M. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):384-96. doi: 10.1089/cap.2015.0027.
PubMed 26091193

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
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Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
Not yet recruitingPhase 2
An Investigation of Mechanisms That Underly Paranoia in Behaviour and Brain That Can Inform Clinical Diagnoses That Include Paranoid Symptoms.
None Volunteer
Recruiting
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Schizophrenia Disorders
Recruiting
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
Delusional Disorder, Brief Psychotic Disorder

All Schizophrenia, Paranoid trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia
ClinicalTrials.gov ID: NCT01190254
Acronym / sponsor ID: P05896
Conditions: Schizophrenia, Paranoid, Schizophrenia, Disorganized, Schizophrenia, Undifferentiated
Keywords: Asenapine, adolescents, schizophrenia, phase IIIb, placebo-controlled
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 306 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 28 Sep 2010 (actual)
Primary completion: 10 Mar 2013 (actual)
Study completion: 1 Apr 2013 (actual)
First posted: 27 Aug 2010 (estimated)
Results: Posted 6 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Asenapine 2.5 mg BID	Experimental	Drug: asenapine 2.5 mgParticipants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks.
Asenapine 5.0 mg BID	Experimental	Drug: asenapine 2.5 mg, Drug: asenapine 5.0 mgParticipants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period.
Placebo	Placebo comparator	Drug: placeboParticipants receive placebo asenapine tablets sublingually BID for 8 weeks.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Each participant must have schizophrenia, diagnosed and confirmed by board-eligible or board certified psychiatrists with at least two years of specialization in pediatric/adolescent psychiatric medicine.
Each participant must be ≥12 years of age and <18 years of age.
Each participant must have a minimum PANSS total score of 80 at Screening and Baseline.
Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution) at Screening and Baseline.
Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline.

Key exclusion criteria (6 listed)

A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with "continuous," "single episode in partial remission," or "single episode in full remission" course specifiers.
A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.
A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder.
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria for substance abuse or dependence (excluding nicotine).
A participant must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
asenapine 2.5 mgAlso: Saphris®, SCH 900274, Org 5222asenapine 2.5 mg tablets for sublingual administration	Drug	Asenapine 2.5 mg BID, Asenapine 5.0 mg BID
asenapine 5.0 mgAlso: Saphris®, SCH 900274, Org 5222asenapine 5.0 mg tablets for sublingual administration	Drug	Asenapine 5.0 mg BID
placeboasenapine-matched placebo tablets for sublingual administration	Drug	Placebo

Primary outcome

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
Time frame: 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 assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.

18 secondary outcomes

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS Positive Subscale Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS Negative Subscale Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56
Time frame: Baseline and Day 56
Total PANSS 30% Responders
Time frame: Baseline up to Day 56
Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study
Time frame: Baseline up to approximately Day 59
Clinical Global Impression of Improvement (CGI-I) Score at Day 56
Time frame: Baseline and Day 56
CGI-I Responders
Time frame: Baseline up to Day 56
Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study
Time frame: Baseline up to approximately Day 58
Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56
Time frame: Baseline and Day 56
Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56
Time frame: Baseline and Day 56

Results and safety

Results posted to the registry on 6 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	102	81
Asenapine 2.5 mg BID	98	81
Asenapine 5.0 mg BID	106	84

Primary outcome: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56

Time frame: Baseline and Day 56. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 77	Asenapine 2.5 mg BID n = 72	Asenapine 5.0 mg BID n = 79
Value	-17.8 (17.8)	-23.7 (18.6)	-25.5 (16.9)

Placebo vs Asenapine 2.5 mg BID: Difference in Least Squares (LS) Means: -4.8 (95% CI -9.9 to 0.4), p = 0.070, Mixed Model for Repeated Measures (MMRM)
Placebo vs Asenapine 5.0 mg BID: Difference in LS Means: -5.6 (95% CI -10.7 to -0.5), p = 0.064, MMRM
Placebo vs Asenapine 2.5 mg BID vs Asenapine 5.0 mg BID: p = 0.064, MMRM

Population analysed: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy Full Analysis Set \[FAS\]); also, to be included an on-treatment Day 56 value of PANSS Total Score must be available for a participant.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days after the last dose of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 102 (2.9%)	23 of 102 (22.5%)	Not reported
Asenapine 2.5 mg BID	3 of 98 (3.1%)	39 of 98 (39.8%)	Not reported
Asenapine 5.0 mg BID	3 of 106 (2.8%)	46 of 106 (43.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26091193Findling RL, Landbloom RP, Mackle M, Pallozzi W, Braat S, Hundt C, Wamboldt MZ, Mathews M. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):384-96. doi: 10.1089/cap.2015.0027.
Individual participant dataSharing planned: No

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Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
Not yet recruitingPhase 2
An Investigation of Mechanisms That Underly Paranoia in Behaviour and Brain That Can Inform Clinical Diagnoses That Include Paranoid Symptoms.
None Volunteer
Recruiting
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Schizophrenia Disorders
Recruiting
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
Delusional Disorder, Brief Psychotic Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing asenapine 2.5 mg and asenapine 5.0 mg in people with Schizophrenia, Paranoid and Schizophrenia, Disorganized, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 (time frame: Baseline and Day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01190254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.