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Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
Placebo
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients, between 18 and 55 years of age
  2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year
  3. Has predominant negative symptoms according to predefined study criteria

  4. 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

Exclusion Criteria:

  1. Patient has a psychiatric disorder other than schizophrenia

  2. 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

  3. 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
  4. Patient has had a myocardial infarction in the last six months
  5. Patient has a family or personal history or symptoms of long QT syndrome
  6. Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening

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, taken as two tablets + background antipsychotic, once daily by mouth

Outcomes

Primary Outcome Measures

Change From Baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) Total Score
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 total score is the sum of item scores. It can range from 16 to a maximum of 96, with higher scores denoting more severe negative symptoms in schizophrenia.

Secondary Outcome Measures

Change From Baseline to Week 26 in the Personal and Social Performance Scale (PSP) Score
The PSP is a validated 100-point (1 to100) single-item rating scale to assess the psychosocial functioning of subjects with schizophrenia. Ratings are based on 4 main areas i.e. (a) socially useful activities, including work and study; (2) personal and social relationships, (3) self-care; and (4) disturbing and aggressive behaviors. The time period assessed is "past month". Higher scores denote better psychosocial functioning
Proportion of Negative Symptom Assessment-16 (NSA-16) Responders at Week 26
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 total score is the sum of item scores. It can range from 16 to a maximum of 96, with higher scores denoting more severe negative symptoms in schizophrenia. NSA-16 responders were defined as patients with at least 20, 30, 50, or 75% percentage improvement in NSA-16 total score from baseline.
Change From Baseline to Week 26 in NSA-16 Global Negative Symptoms Rating
The global negative symptoms rating of the NSA-16 assesses overall severity on a 7-point scale from 1 to 7, with higher scores denoting more severe negative symptoms in schizophrenia.
Change From Baseline (CFB) to Week 26 in NSA-16 Domain Scores
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 domain scores are the sum of item scores in each domain i.e. communication (min score 4, max score 24), emotion/affect (min 3, max 18), social involvement (min 3, max 18), motivation (min 4, max 24), and retardation (min 2, max 12); with higher scores denoting more severe negative symptoms in schizophrenia.
Change From Baseline to Week 26 in the Clinical Global Impression of Schizophrenia Scale-Severity (CGI-SCH-S) of Negative Symptoms Score
The CGI-SCH-S is a clinician-rated, 7-point scale to evaluate positive, negative, depressive, cognitive symptoms and overall severity in schizophrenia. For the purpose of this study, only the negative symptoms were evaluated. The score could range from 1 (normal, not ill) to 7 (among the most severely ill).
Clinical Global Impression of Schizophrenia Scale-Improvement (CGI-SCH-I) of Negative Symptoms Score at Week 26
The CGI-SCH-I is a clinician-rated, 7-point scale to evaluate change from baseline in positive, negative, depressive, cognitive symptoms and overall severity in schizophrenia. For the purpose of this study, only the changes in negative symptoms from baseline were evaluated. The score could range from 1 (very much improved) to 7 (very much worse).
Proportion of CGI-SCH-I Responders (CGI-SCH-I Score of 1 or 2) at Week 26; Observed Cases
The CGI-SCH-I is a clinician-rated, 7-point scale that is designed to evaluate change from baseline in positive, negative, depressive, cognitive symptoms and overall severity in schizophrenia. For the purpose of this study, only the changes in negative symptoms from baseline were evaluated. The 7-point scores range from 1 (very much improved) to 7 (very much worse); responders were defined as those with CGI-SCH-I of 1 or 2. The analysis includes observed cases; missing cases were not imputed.
Change From Baseline to Week 26 in the Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a 30-item scale to evaluate the presence, absence, and severity of schizophrenia symptoms. Items are scored over the past week (7 days) on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score is the sum of scores and ranges from a minimum of 30 to a maximum of 210. Higher scores denote more severe symptoms.
Change From Baseline (CFB) to Week 26 in PANSS Subscale Scores
The PANSS is a 30-item scale to evaluate the presence, absence, and severity of schizophrenia symptoms. Items are scored over the past week (7 days) on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS has 3 subscales that are the sums of the respective item scores, including the positive scale (min 7, max 49), negative scale (min 7, max 49), and general psychopathology scale (min 16, max 112). Higher scores denote more severe symptoms.
Change From Baseline to Week 26 in Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score
The BACS is a performance-based assessment of treatment-related changes in cognition, assessing 6 domains of verbal memory and learning; working memory; motor function; verbal fluency; attention and speed of processing; and executive function. The 6 domains with their raw scores are: verbal memory 0-75; digit sequencing 0-28; token motor 0-100; verbal fluency 0-225; symbol coding 0-110; Tower of London 0-22. For each domain, higher scores reflect better cognition. Raw scores are converted to age and sex-corrected normalized scores. The BACS composite score is calculated as the mean of the normalized scores from the 6 subscale scores, standardized so that the mean of the BACS composite score in the healthy normative sample is 50 and the standard deviation is 10.
Change From Baseline to Week 26 in 10-item Drug Attitude Inventory (DAI-10) Score
The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a subject who is fully adherent to the prescribed medication would answer as "True" and 4 items (2, 5, 6, and 8) that a subject who is fully adherent to the prescribed medication would answer as "False." A correct answer is scored +1 and an incorrect answer is scored -1. The total score is the sum of pluses and minuses, which can range from -10 to 10 in increments of 2. A positive total score indicates a positive subjective response (adherent) and a negative total score indicates a negative subjective response (non-adherent). Higher scores denote better adherence.
Change From Baseline to Week 26 in Karolinska Sleepiness Scale (KSS) Score
The KSS is a self-reported subjective measure of a subject's level of drowsiness. Respondents must choose statements that most accurately describe their level of sleepiness over the past 7 days. Scoring was based on a 9-point verbally anchored scale ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). Higher scores denoted more drowsiness.

Full Information

First Posted
November 18, 2016
Last Updated
December 1, 2020
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02970305
Brief Title
Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 4, 2016 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 28, 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 the negative symptoms 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
403 (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, taken as two tablets + background antipsychotic, 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 26 in the Negative Symptom Assessment-16 (NSA-16) Total Score
Description
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 total score is the sum of item scores. It can range from 16 to a maximum of 96, with higher scores denoting more severe negative symptoms in schizophrenia.
Time Frame
From baseline to Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 26 in the Personal and Social Performance Scale (PSP) Score
Description
The PSP is a validated 100-point (1 to100) single-item rating scale to assess the psychosocial functioning of subjects with schizophrenia. Ratings are based on 4 main areas i.e. (a) socially useful activities, including work and study; (2) personal and social relationships, (3) self-care; and (4) disturbing and aggressive behaviors. The time period assessed is "past month". Higher scores denote better psychosocial functioning
Time Frame
From baseline to Week 26
Title
Proportion of Negative Symptom Assessment-16 (NSA-16) Responders at Week 26
Description
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 total score is the sum of item scores. It can range from 16 to a maximum of 96, with higher scores denoting more severe negative symptoms in schizophrenia. NSA-16 responders were defined as patients with at least 20, 30, 50, or 75% percentage improvement in NSA-16 total score from baseline.
Time Frame
From baseline to Week 26
Title
Change From Baseline to Week 26 in NSA-16 Global Negative Symptoms Rating
Description
The global negative symptoms rating of the NSA-16 assesses overall severity on a 7-point scale from 1 to 7, with higher scores denoting more severe negative symptoms in schizophrenia.
Time Frame
From baseline to Week 26
Title
Change From Baseline (CFB) to Week 26 in NSA-16 Domain Scores
Description
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 domain scores are the sum of item scores in each domain i.e. communication (min score 4, max score 24), emotion/affect (min 3, max 18), social involvement (min 3, max 18), motivation (min 4, max 24), and retardation (min 2, max 12); with higher scores denoting more severe negative symptoms in schizophrenia.
Time Frame
From baseline (BL) to Week 26
Title
Change From Baseline to Week 26 in the Clinical Global Impression of Schizophrenia Scale-Severity (CGI-SCH-S) of Negative Symptoms Score
Description
The CGI-SCH-S is a clinician-rated, 7-point scale to evaluate positive, negative, depressive, cognitive symptoms and overall severity in schizophrenia. For the purpose of this study, only the negative symptoms were evaluated. The score could range from 1 (normal, not ill) to 7 (among the most severely ill).
Time Frame
From baseline to Week 26
Title
Clinical Global Impression of Schizophrenia Scale-Improvement (CGI-SCH-I) of Negative Symptoms Score at Week 26
Description
The CGI-SCH-I is a clinician-rated, 7-point scale to evaluate change from baseline in positive, negative, depressive, cognitive symptoms and overall severity in schizophrenia. For the purpose of this study, only the changes in negative symptoms from baseline were evaluated. The score could range from 1 (very much improved) to 7 (very much worse).
Time Frame
From baseline to Week 26
Title
Proportion of CGI-SCH-I Responders (CGI-SCH-I Score of 1 or 2) at Week 26; Observed Cases
Description
The CGI-SCH-I is a clinician-rated, 7-point scale that is designed to evaluate change from baseline in positive, negative, depressive, cognitive symptoms and overall severity in schizophrenia. For the purpose of this study, only the changes in negative symptoms from baseline were evaluated. The 7-point scores range from 1 (very much improved) to 7 (very much worse); responders were defined as those with CGI-SCH-I of 1 or 2. The analysis includes observed cases; missing cases were not imputed.
Time Frame
From baseline to Week 26
Title
Change From Baseline to Week 26 in the Positive and Negative Syndrome Scale (PANSS) Total Score
Description
The PANSS is a 30-item scale to evaluate the presence, absence, and severity of schizophrenia symptoms. Items are scored over the past week (7 days) on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score is the sum of scores and ranges from a minimum of 30 to a maximum of 210. Higher scores denote more severe symptoms.
Time Frame
From baseline to Week 26
Title
Change From Baseline (CFB) to Week 26 in PANSS Subscale Scores
Description
The PANSS is a 30-item scale to evaluate the presence, absence, and severity of schizophrenia symptoms. Items are scored over the past week (7 days) on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS has 3 subscales that are the sums of the respective item scores, including the positive scale (min 7, max 49), negative scale (min 7, max 49), and general psychopathology scale (min 16, max 112). Higher scores denote more severe symptoms.
Time Frame
From baseline (BL) to Week 26
Title
Change From Baseline to Week 26 in Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score
Description
The BACS is a performance-based assessment of treatment-related changes in cognition, assessing 6 domains of verbal memory and learning; working memory; motor function; verbal fluency; attention and speed of processing; and executive function. The 6 domains with their raw scores are: verbal memory 0-75; digit sequencing 0-28; token motor 0-100; verbal fluency 0-225; symbol coding 0-110; Tower of London 0-22. For each domain, higher scores reflect better cognition. Raw scores are converted to age and sex-corrected normalized scores. The BACS composite score is calculated as the mean of the normalized scores from the 6 subscale scores, standardized so that the mean of the BACS composite score in the healthy normative sample is 50 and the standard deviation is 10.
Time Frame
From baseline to Week 26
Title
Change From Baseline to Week 26 in 10-item Drug Attitude Inventory (DAI-10) Score
Description
The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a subject who is fully adherent to the prescribed medication would answer as "True" and 4 items (2, 5, 6, and 8) that a subject who is fully adherent to the prescribed medication would answer as "False." A correct answer is scored +1 and an incorrect answer is scored -1. The total score is the sum of pluses and minuses, which can range from -10 to 10 in increments of 2. A positive total score indicates a positive subjective response (adherent) and a negative total score indicates a negative subjective response (non-adherent). Higher scores denote better adherence.
Time Frame
From baseline to Week 26
Title
Change From Baseline to Week 26 in Karolinska Sleepiness Scale (KSS) Score
Description
The KSS is a self-reported subjective measure of a subject's level of drowsiness. Respondents must choose statements that most accurately describe their level of sleepiness over the past 7 days. Scoring was based on a 9-point verbally anchored scale ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). Higher scores denoted more drowsiness.
Time Frame
From baseline to Week 26

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: Adult patients, between 18 and 55 years of age A clinical diagnosis of schizophrenia with a minimum duration of 1 year Has predominant negative symptoms according to predefined study criteria 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 Exclusion Criteria: Patient has a psychiatric disorder other than schizophrenia 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 has a family or personal history or symptoms of long QT syndrome Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening 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
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
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
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
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
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
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
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
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
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
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
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
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
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
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A4M4
Country
Canada
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L1C1
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3QA 1A1
Country
Canada
City
Toronto
ZIP/Postal Code
M6J 1H4
Country
Canada
City
Hradec Králové
State/Province
Vekose
ZIP/Postal Code
50341
Country
Czechia
City
Plzen
ZIP/Postal Code
31200
Country
Czechia
City
Praha 10
ZIP/Postal Code
10000
Country
Czechia
City
Praha 10
ZIP/Postal Code
10600
Country
Czechia
City
Praha 6
ZIP/Postal Code
16000
Country
Czechia
City
Říčany
ZIP/Postal Code
25101
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
Budapest
ZIP/Postal Code
1084
Country
Hungary
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Pecs
ZIP/Postal Code
7633
Country
Hungary
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 Region
ZIP/Postal Code
188820
Country
Russian Federation
City
Plekhanovo
State/Province
Lipetsk Region
ZIP/Postal Code
399313
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620030
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
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
355000
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
Kovin
ZIP/Postal Code
26220
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
City
Barcelona
ZIP/Postal Code
08830
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
City
Valladolid
ZIP/Postal Code
47016
Country
Spain
City
Zamora
ZIP/Postal Code
49021
Country
Spain
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
Kherson
ZIP/Postal Code
73488
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
Lviv
ZIP/Postal Code
79017
Country
Ukraine
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
City
Odessa
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
20708
Country
Ukraine
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36190440
Citation
Darwish M, Bugarski-Kirola D, Passarell J, Owen J, Jaworowicz D, DeKarske D, Stankovic S. Pimavanserin Exposure-Response Analyses in Patients With Schizophrenia: Results From the Phase 2 ADVANCE Study. J Clin Psychopharmacol. 2022 Nov-Dec 01;42(6):544-551. doi: 10.1097/JCP.0000000000001611. Epub 2022 Oct 3.
Results Reference
derived
PubMed Identifier
34861170
Citation
Bugarski-Kirola D, Arango C, Fava M, Nasrallah H, Liu IY, Abbs B, Stankovic S. Pimavanserin for negative symptoms of schizophrenia: results from the ADVANCE phase 2 randomised, placebo-controlled trial in North America and Europe. Lancet Psychiatry. 2022 Jan;9(1):46-58. doi: 10.1016/S2215-0366(21)00386-2. Epub 2021 Nov 30.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)

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