Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
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| ClinicalTrials.gov Identifier: NCT02970292 |
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Recruitment Status :
Completed
First Posted : November 22, 2016
Results First Posted : June 17, 2020
Last Update Posted : June 17, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Pimavanserin Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 396 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia |
| Actual Study Start Date : | October 26, 2016 |
| Actual Primary Completion Date : | May 28, 2019 |
| Actual Study Completion Date : | June 25, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pimavanserin
Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
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Drug: Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg , taken as two tablets once daily by mouth |
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Placebo Comparator: Placebo
Placebo + background antipsychotic, taken as two tablets, once daily by mouth
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Drug: Placebo
Placebo, taken as two tablets, once daily by mouth |
- Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: From baseline to Week 6 ]The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms.
- Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: From baseline to Week 6 ]The CGI-S is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-S score denotes greater severity of the disorder.
- 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 [ Time Frame: From baseline to Week 6 ]
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme).
The PANSS positive subscale score can range from 7 to 49; the PANSS negative subscale score can range from 7 to 49; the PANSS general psychopathology scale score can range from 16 to 112.
For each of the subscale scores, a higher score signifies greater severity of schizophrenia symptoms.
- PANSS Responders [ Time Frame: From baseline to Week 6 ]Porportion of patients showing a PANSS response of >=20% or >=30% reduction in PANSS total score PANSS total score reduction signifies improvement.
- Clinical Global Impression-Improvement (CGI-I) Response [ Time Frame: From baseline to Week 6 ]
The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.
A CGI-I score of 1 or 2 was counted as response. The Analysis was performed twice; once including missing values as non-responders (MN) and once including only observed cases (OC).
- Clinical Global Impression-Improvement (CGI-I) Score at Week 6 [ Time Frame: From baseline to Week 6 ]The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.
- Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score [ Time Frame: From baseline to Week 6 ]The PSP is a validated 100-point (1 to100) single-item rating scale to assess the psychosocial functioning of patients with schizophrenia. The maximum score is 100. Higher scores denote better psychosocial functioning.
- Drug Attitude Inventory (DAI-10) [ Time Frame: From baseline to Week 6 ]The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a patient who is fully adherent to study medication would answer as "True" and 4 items (2, 5, 6, and 8) that a patient who is fully adherent to study medication would answer as "False." A correct answer is scored +1 and an incorrect answer is scored -1; the total score is derived as overall sum. The score can range from -10 to 10. Positive total scores indicate adherence and negative total scores indicate non-adherence. Higher scores denote better adherence.
- Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score [ Time Frame: From baseline to Week 6 ]The KSS is a self-reported measure of a patient's level of drowsiness. In this study, drowsiness was to be rated during the last week (7 days). Scoring is based on a 9-point verbally anchored scale ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). The maximum score is 9. Higher scores denote more drowsiness.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults patients, between 18 and 55 years of age
- A clinical diagnosis of schizophrenia with a minimum duration of 1 year
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The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:
- Aripiprazole
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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
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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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970292
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Documents provided by ACADIA Pharmaceuticals Inc.:
| Responsible Party: | ACADIA Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT02970292 |
| Other Study ID Numbers: |
ACP-103-034 2016-003434-24 ( EudraCT Number ) |
| First Posted: | November 22, 2016 Key Record Dates |
| Results First Posted: | June 17, 2020 |
| Last Update Posted: | June 17, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Pimavanserin Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Antiparkinson Agents Anti-Dyskinesia Agents Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |