Back to resultsEfficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pimavanserin
Placebo
Arm Description
Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
Placebo + background antipsychotic, taken as two tablets, once daily by mouth
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
PANSS Responders
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
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
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
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)
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
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.
Full Information
NCT ID
NCT02970292
First Posted
November 18, 2016
Last Updated
May 29, 2020
Sponsor
ACADIA Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02970292
Brief Title
Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
May 28, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pimavanserin
Arm Type
Experimental
Arm Description
Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + background antipsychotic, taken as two tablets, once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
Pimavanserin 34 mg, 20 mg, or 10 mg , taken as two tablets once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, taken as two tablets, once daily by mouth
Primary Outcome Measure Information:
Title
Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score
Description
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.
Time Frame
From baseline to Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score
Description
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.
Time Frame
From baseline to Week 6
Title
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
Description
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.
Time Frame
From baseline to Week 6
Title
PANSS Responders
Description
Porportion of patients showing a PANSS response of >=20% or >=30% reduction in PANSS total score PANSS total score reduction signifies improvement.
Time Frame
From baseline to Week 6
Title
Clinical Global Impression-Improvement (CGI-I) Response
Description
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).
Time Frame
From baseline to Week 6
Title
Clinical Global Impression-Improvement (CGI-I) Score at Week 6
Description
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.
Time Frame
From baseline to Week 6
Title
Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score
Description
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.
Time Frame
From baseline to Week 6
Title
Drug Attitude Inventory (DAI-10)
Description
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.
Time Frame
From baseline to Week 6
Title
Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score
Description
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.
Time Frame
From baseline to Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
City
Tserova Koria
ZIP/Postal Code
5047
Country
Bulgaria
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
City
Veliko Tarnovo
ZIP/Postal Code
5047
Country
Bulgaria
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L1C1
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Toronto
ZIP/Postal Code
M6J 1H4
Country
Canada
City
Hradec Králové
ZIP/Postal Code
503 41
Country
Czechia
City
Plzen
ZIP/Postal Code
312 00
Country
Czechia
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
City
Praha 10
ZIP/Postal Code
106 00
Country
Czechia
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
City
Říčany
ZIP/Postal Code
251 01
Country
Czechia
City
Kalocsa
State/Province
Bács-Kiskun Megya
ZIP/Postal Code
6300
Country
Hungary
City
Budapest
State/Province
Pest Megye
ZIP/Postal Code
1036
Country
Hungary
City
Budapest
State/Province
Pest Megye
ZIP/Postal Code
1083
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Pecs
ZIP/Postal Code
7633
Country
Hungary
City
Kaunas
ZIP/Postal Code
44279
Country
Lithuania
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
City
Silute
ZIP/Postal Code
99142
Country
Lithuania
City
Vilnius
ZIP/Postal Code
09112
Country
Lithuania
City
Białystok
ZIP/Postal Code
15 756
Country
Poland
City
Bydgoszcz
ZIP/Postal Code
85 080
Country
Poland
City
Lublin
ZIP/Postal Code
20 080
Country
Poland
City
Lublin
ZIP/Postal Code
20 582
Country
Poland
City
Pruszcz Gdański
ZIP/Postal Code
83 000
Country
Poland
City
Roshchino
State/Province
Leningrad
ZIP/Postal Code
188820
Country
Russian Federation
City
Plekhanovo
State/Province
Lipetsk
ZIP/Postal Code
399313
Country
Russian Federation
City
Tonnel'nyy
State/Province
Stavropol
ZIP/Postal Code
357034
Country
Russian Federation
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
195112
Country
Russian Federation
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
City
Stavropol'
ZIP/Postal Code
355038
Country
Russian Federation
City
Voronezh
ZIP/Postal Code
394024
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Kovin
ZIP/Postal Code
26 220
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
City
Kherson
State/Province
Vil. Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
City
Hlevakha
ZIP/Postal Code
08631
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
City
Kyiv
ZIP/Postal Code
01133
Country
Ukraine
City
Kyiv
ZIP/Postal Code
02192
Country
Ukraine
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
City
Kyiv
ZIP/Postal Code
08631
Country
Ukraine
City
Odesa
ZIP/Postal Code
65014
Country
Ukraine
City
Oleksandrivka
ZIP/Postal Code
67513
Country
Ukraine
City
Poltava
ZIP/Postal Code
36013
Country
Ukraine
City
Smila
ZIP/Postal Code
08631
Country
Ukraine
City
Smila
ZIP/Postal Code
20708
Country
Ukraine
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
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