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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970292
• Other study ID #: ACP-103-034
• Secondary ID: 2016-003434-24
• Status: Completed
• Phase: Phase 3
• Start date: October 26, 2016
• Est. completion date: June 25, 2019

Study information

• Verified date: May 2020
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: June 25, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Adults patients, between 18 and 55 years of age

2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year

3. 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

4. Has had a partial but inadequate response to antipsychotic treatment

5. Has a history of response to antipsychotic treatment other than clozapine

Exclusion Criteria:

1. Patient has a psychiatric disorder other than schizophrenia

2. Patient has a history of resistance to antipsychotic treatment

3. 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

4. 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

5. Patient has had a myocardial infarction in the last six months

6. 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).

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg , taken as two tablets once daily by mouth
• Placebo
Placebo, taken as two tablets, once daily by mouth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Hungary,  Lithuania,  Poland,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score	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.	From baseline to Week 6
Secondary	Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score	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.	From baseline to Week 6
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	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.	From baseline to Week 6
Secondary	PANSS Responders	Porportion of patients showing a PANSS response of >=20% or >=30% reduction in PANSS total score PANSS total score reduction signifies improvement.	From baseline to Week 6
Secondary	Clinical Global Impression-Improvement (CGI-I) Response	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).	From baseline to Week 6
Secondary	Clinical Global Impression-Improvement (CGI-I) Score at 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.	From baseline to Week 6
Secondary	Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score	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.	From baseline to Week 6
Secondary	Drug Attitude Inventory (DAI-10)	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.	From baseline to Week 6
Secondary	Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score	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.	From baseline to Week 6