Clinical trial NCT02970292: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-22
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: From baseline to Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score
timeFrame: From baseline to Week 6
measure: 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
timeFrame: From baseline to Week 6
measure: PANSS Responders
timeFrame: From baseline to Week 6
measure: Clinical Global Impression-Improvement (CGI-I) Response
timeFrame: From baseline to Week 6
measure: Clinical Global Impression-Improvement (CGI-I) Score at Week 6
timeFrame: From baseline to Week 6
measure: Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score
timeFrame: From baseline to Week 6
measure: Drug Attitude Inventory (DAI-10)
timeFrame: From baseline to Week 6
measure: Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score
timeFrame: From baseline to Week 6
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Rogers
country: United States
state: Arkansas
city: Bellflower
country: United States
state: California
city: Cerritos
country: United States
state: California
city: Culver City
country: United States
state: California
city: Lemon Grove
country: United States
state: California
city: Long Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Lauderhill
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Lake Charles
country: United States
state: Louisiana
city: Catonsville
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Cedarhurst
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Charleston
country: United States
state: South Carolina
city: Richardson
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burgas
country: Bulgaria
city: Pazardzhik
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Targovishte
country: Bulgaria
city: Tserova Koria
country: Bulgaria
city: Varna
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
city: Vratsa
country: Bulgaria
city: Chatham
country: Canada
state: Ontario
city: Montréal
country: Canada
state: Quebec
city: Toronto
country: Canada
city: Hradec Králové
country: Czechia
city: Plzen
country: Czechia
city: Praha 10
country: Czechia
city: Praha 10
country: Czechia
city: Praha 6
country: Czechia
city: Říčany
country: Czechia
city: Kalocsa
country: Hungary
state: Bács-Kiskun Megya
city: Budapest
country: Hungary
state: Pest Megye
city: Budapest
country: Hungary
state: Pest Megye
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Silute
country: Lithuania
city: Vilnius
country: Lithuania
city: Białystok
country: Poland
city: Bydgoszcz
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Pruszcz Gdański
country: Poland
city: Roshchino
country: Russian Federation
state: Leningrad
city: Plekhanovo
country: Russian Federation
state: Lipetsk
city: Tonnel'nyy
country: Russian Federation
state: Stavropol
city: Arkhangelsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Stavropol'
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Kovin
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Kherson
country: Ukraine
state: Vil. Stepanivka
city: Dnipro
country: Ukraine
city: Hlevakha
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Odesa
country: Ukraine
city: Oleksandrivka
country: Ukraine
city: Poltava
country: Ukraine
city: Smila
country: Ukraine
city: Smila
country: Ukraine
city: Vinnytsia
country: Ukraine
Study officials:
References: