Clinical trial NCT01098110: 6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)
Official title: A Multicenter, Randomized, Double-blind, Fixed-dose, 6-week Trial of the Efficacy and Safety of Asenapine Compared With Placebo in Subjects With an Acute Exacerbation of Schizophrenia (Phase 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 532
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or undifferentiated (295.90) subtype
* minimum Positive and Negative Syndrome Scale (PANSS) total score of 60 at screening and Baseline.
* participant had a score of at least 4 in two or more of 5 items in the positive subscale of the PANSS at Screening and Baseline.
* participant confirmed by the investigator to be experiencing an acute exacerbation of schizophrenia as evidenced by ALL of the following:

  * at the screening test, the duration of the current episode was no more than 2 months;
  * current symptoms represented a dramatic and substantial change compared to the participant's symptomatic state prior to the emergence of the current episode;
  * participant was in need of changing medication or dosage to treat newly appeared or worsened positive symptoms.
* participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Baseline;
* responded positively to an antipsychotic medication in a prior episode.
* discontinued the use of all prohibited concomitant medications, with last dose taken no later than the evening prior to the baseline visit (For depot neuroleptic, discontinuation must have occurred more than 3 months prior to randomization).
* participants must agree to inpatient status for screening period and for up to 42 days of dosing and, for out-patient phase, had a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) whom the investigator accepts and who has agreed to provide support to the participant to ensure compliance with study treatment, out-patient visits, and protocol procedures.

Exclusion Criteria:

* not be treatment-refractory defined by the following criteria: (1) had been treated with at least two different atypical anti-psychotic agents at dosages equivalent to or greater than 600 mg/day of chlorpromazine (12 mg /day of haloperidol) for more than 4 weeks, each without clinical response, or (2) has received clozapine for 12 weeks immediately preceding the screening.
* not have received treatment with 3 or more antipsychotic drugs, or dose-equivalents higher than 18 mg/day of haloperidol (equivalent 900 mg/day of chlorpromazine) within one month prior to randomization.
* not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophreniform disorder, or schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission
* not have a concurrent psychiatric disorder other than schizophrenia coded on Axis I; not have a primary diagnosis other than schizophrenia
* not have had a known diagnosis of borderline personality disorder, mental retardation or organic brain disorder.
* not have a 20% or greater decrease in PANSS total score from screening to baseline
* not have an imminent risk of self-harm or harm to others, in the investigator's opinion.
* not have a substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
* not be currently under involuntary in-patient confinement.
* not been previously treated with asenapine.

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
timeFrame: Baseline and Day 42
Secondary outcomes:
measure: Change From Baseline in PANSS Positive Symptom Score.
timeFrame: Baseline and Day 42
measure: Change From Baseline in PANSS Negative Symptom Score.
timeFrame: Baseline and Day 42
measure: Change From Baseline in PANSS General Psychopathology Score.
timeFrame: Baseline and Day 42
measure: Change From Baseline in PANSS Marder Factor Positive Symptom Score.
timeFrame: Baseline and Day 42
measure: Change From Baseline in PANSS Marder Factor Negative Symptom Score.
timeFrame: Baseline and Day 42
measure: Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score.
timeFrame: Baseline and Day 42
measure: Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score.
timeFrame: Baseline and Day 42
measure: Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score.
timeFrame: Baseline and Day 42
measure: Percentage of Participants Who Were PANSS Responders.
timeFrame: Day 42
measure: Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score.
timeFrame: Baseline and Day 42
measure: Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders.
timeFrame: Day 42
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kinoshita T, Bai YM, Kim JH, Miyake M, Oshima N. Efficacy and safety of asenapine in Asian patients with an acute exacerbation of schizophrenia: a multicentre, randomized, double-blind, 6-week, placebo-controlled study. Psychopharmacology (Berl). 2016 Jul;233(14):2663-74. doi: 10.1007/s00213-016-4295-9. Epub 2016 Jun 8.