Phase 3 N=396 Randomized Quadruple-blind Treatment

Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT02970292 ↗

Enrolled (actual)

396

Serious AEs

1.0%

Results posted

Jun 2020

Primary outcome: Primary: Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score — 88.3; 88.1; -15.3; -13.4 score on a scale — p=0.0940

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pimavanserin (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: ACADIA Pharmaceuticals Inc.
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score	88.3; 88.1; -15.3; -13.4	0.0940
SECONDARY Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score	4.6; 4.6; -0.8; -0.7	—
SECONDARY Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores, i.e. PANSS Positive Subscale Score, PANSS Negative Subscale Score and PANSS General Psychopathological Scale Score	23.0; 22.8; -5.4; -4.9; 23.0; 23.1	—
SECONDARY PANSS Responders	109; 99; 71; 67	—
SECONDARY Clinical Global Impression-Improvement (CGI-I) Response	68; 65; 68; 65	—
SECONDARY Clinical Global Impression-Improvement (CGI-I) Score at Week 6	2.8; 3.0	—
SECONDARY Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score	51.8; 51.6; 6.8; 5.7	—
SECONDARY Drug Attitude Inventory (DAI-10)	5.6; 5.8; 0.4; 0.4	—
SECONDARY Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score	4.6; 4.7; -0.5; -0.2	—

Summary

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia

Eligibility Criteria

Inclusion Criteria

Adults patients, between 18 and 55 years of age
A clinical diagnosis of schizophrenia with a minimum duration of 1 year
The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:
Aripiprazole
Aripiprazole long-acting injectables:
Abilify Maintena®
Aristada®
Risperidone
Risperidone long-acting injection
Olanzapine
Lurasidone
Cariprazine
Brexpiprazole
Asenapine
Has had a partial but inadequate response to antipsychotic treatment
Has a history of response to antipsychotic treatment other than clozapine

Exclusion Criteria

Patient has a psychiatric disorder other than schizophrenia
Patient has a history of resistance to antipsychotic treatment
A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation

Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
Patient has had a myocardial infarction in the last six months
Patient is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02970292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.