Phase 3
Completed N=396
Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
Source: ClinicalTrials.gov NCT02970292 ↗Enrolled (actual)
396
Serious AEs
1.0%
Results posted
Jun 2020
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
3citations · ~2 / year
Adherence to Background Antipsychotic and Pimavanserin in Patients with Schizophrenia: Post Hoc Analyses from the ENHANCE and ADVANCE Studies.
Summary
To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia
Linked Publications
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Adherence to Background Antipsychotic and Pimavanserin in Patients with Schizophrenia: Post Hoc Analyses from the ENHANCE and ADVANCE Studies.
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 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02970292) and the linked publication. 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. Informational only — not medical advice.