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CompletedNCT00281320Updated Feb 9, 2022Results posted

Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

A Phase 3 interventional study of Asenapine in Psychosis, sponsored by Organon and Co. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

02

Conditions studied

  • Psychosis
03

In context

Psychotic Disorders

1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.

This study's enrollment of 122 is above the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Elderly subjects with psychosis

Exclusion criteria

Exclusion Criteria:

  • Have an uncontrolled, unstable clinically significant

medical condition.

  • Have an established diagnosis of dementia
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    Asenapine 2-10 mg BID

    Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)

    Drug: Asenapine

  • Experimental
    Asenapine 5-10mg BID

    Dose titration from 5 mg to 10 mg BID

    Drug: Asenapine

Interventions

  • DrugAsenapine

    Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).

    Also known as: Saphris

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Experienced an Adverse Event

    Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).

    Time frame: Up to Day 42 (treatment period)

  2. Number of Participants Who Discontinued Because of an Adverse Event

    Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).

    Time frame: up to 30 days after study medication stop date

  3. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax

    Tmax defined as time to peak concentration.

    Time frame: Day 4 or 8

  4. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax

    Cmax defined as peak concentration.

    Time frame: Day 4 or 8

  5. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax

    dn-Cmax is defined as dose normalized peak concentration.

    Time frame: Day 4 or 8

  6. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin

    Cmin defined as pre-dose concentration.

    Time frame: Day 4 or 8

  7. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12

    AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.

    Time frame: Day 4 or 8

  8. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12

    dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.

    Time frame: Day 4 or 8

07

Results

Posted Sep 9, 2010

Participant flow

Participant flow — Overall Study
MilestoneAsenapine 2-10 mg Twice Daily (BID)Asenapine 5-10 mg BID
Started6161
Completed3640
Not completed2521
Withdrew: Adverse event129
Withdrew: Lack of efficacy43
Withdrew: Withdrawal by subject56
Withdrew: Lost to follow-up12
Withdrew: Other31

Outcome measures

PrimaryNumber of Participants Who Experienced an Adverse Event

Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).

Time frame:
Up to Day 42 (treatment period)
Reported as:
Number · Participants
Number of Participants Who Experienced an Adverse Event
ParticipantsAsenapine 2-10 mg Twice Daily (BID)Asenapine 5-10 mg BID
Number of Participants Who Experienced an Adverse Event4444
PrimaryNumber of Participants Who Discontinued Because of an Adverse Event

Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).

Time frame:
up to 30 days after study medication stop date
Reported as:
Number · participants
Number of Participants Who Discontinued Because of an Adverse Event
participantsAsenapine 2-10 mg Twice Daily (BID)Asenapine 5-10 mg BID
Number of Participants Who Discontinued Because of an Adverse Event129
PrimaryPharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax

Tmax defined as time to peak concentration.

Time frame:
Day 4 or 8
Reported as:
Median · hours
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax
hoursAsenapine 5mg BID Day 4Asenapine 10mg BID Day 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax1.00 (0.417 to 4.23)1.06 (0.417 to 4.08)
PrimaryPharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax

Cmax defined as peak concentration.

Time frame:
Day 4 or 8
Reported as:
Mean · ng/mL
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax
ng/mLAsenapine 5mg BID Day 4Asenapine 10mg BID Day 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax6.01 ± 3.8910.3 ± 6.71
PrimaryPharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax

dn-Cmax is defined as dose normalized peak concentration.

Time frame:
Day 4 or 8
Reported as:
Mean · ng/mL/mg
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax
ng/mL/mgAsenapine 5mg BID Day 4Asenapine 10mg BID Day 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax1.20 ± 0.7781.03 ± 0.671
PrimaryPharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin

Cmin defined as pre-dose concentration.

Time frame:
Day 4 or 8
Reported as:
Mean · ng/mL
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin
ng/mLAsenapine 5mg BID Day 4Asenapine 10mg BID Day 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin2.28 ± 1.874.06 ± 2.70
PrimaryPharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12

AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.

Time frame:
Day 4 or 8
Reported as:
Mean · ng*h/mL
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12
ng*h/mLAsenapine 5mg BID Day 4Asenapine 10mg BID Day 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-1238.6 ± 21.170.3 ± 41.8
PrimaryPharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12

dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.

Time frame:
Day 4 or 8
Reported as:
Mean · ng*h/mL/mg
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12
ng*h/mL/mgAsenapine 5mg BID Day 4Asenapine 10mg BID Day 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-127.72 ± 4.227.03 ± 4.18

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Asenapine 2-10mg BID—6/61 (9.8%)21/61 (34.4%)
Asenapine 5-10mg BID—3/61 (4.9%)21/61 (34.4%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventAsenapine 2-10mg BIDAsenapine 5-10mg BID
Cardio-respiratory arrestCardiac disorders1/610/61
Ventricular extrasystolesCardiac disorders0/611/61
FallInjury, poisoning and procedural complications1/610/61
Hip fractureInjury, poisoning and procedural complications1/610/61
Metastases to pleuraNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/610/61
Extrapyramidal disorderNervous system disorders1/610/61
ManiaPsychiatric disorders0/611/61
Mental status changesPsychiatric disorders1/610/61
Psychotic disorderPsychiatric disorders1/610/61
SchizophreniaPsychiatric disorders0/611/61
Most frequent other events
Most frequent other events
EventAsenapine 2-10mg BIDAsenapine 5-10mg BID
HypertensionVascular disorders7/613/61
Blood pressure increasedInvestigations0/615/61
ParkinsonismNervous system disorders1/615/61
SomnolenceNervous system disorders5/613/61
AstheniaGeneral disorders4/612/61
Urinary tract infectionInfections and infestations4/610/61
DizzinessNervous system disorders4/612/61
HeadacheNervous system disorders4/614/61
AnxietyPsychiatric disorders0/614/61

Baseline characteristics

Age, Continuous
Age, Continuous(years)Asenapine 2-10 mg BIDAsenapine 5-10 mg BIDTotal
Mean70.5 ± 4.672.0 ± 5.871.2 ± 5.2
Sex: Female, Male
Sex: Female, Male(Participants)Asenapine 2-10 mg BIDAsenapine 5-10 mg BIDTotal
Female414788
Male201434
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13. PubMed 21755540 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00281320
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Jan 24, 2006
Start date
Feb 2006
Primary completion
Dec 2008
Completion
Dec 2008
Results posted
Sep 9, 2010
Last update
Feb 9, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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