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

Last updated: May 29, 2020
Sponsor: ACADIA Pharmaceuticals Inc.
Overall Status: Completed

Phase

3

Condition

Psychosis

Tourette's Syndrome

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT02970292
ACP-103-034
2016-003434-24
  • Ages 18-55
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 oneof the antipsychotics listed below:

  • Aripiprazole

  • Aripiprazole long-acting injectables:

  • Abilify Maintena®

  • Aristada®

  • Risperidone

  • Risperidone long-acting injection

  • Olanzapine

  • Lurasidone

  • Cariprazine

  • Brexpiprazole

  • Asenapine

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

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

Exclusion

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 testedprohibited substance of potential abuse, except marijuana a. Patients with a result indicating the presence of marijuana are permitted if theyagree to abstain from marijuana use during the study and the medical monitor approvesthe subject's participation

  4. Patient has current evidence of a serious and/or unstable psychiatric, neurologic,cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or othermedical disorder, including cancer or malignancies, which would affect the patient'sability 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 familyor personal history or symptoms of long QT syndrome Patients will be evaluated at screening to ensure that all criteria for study participationare met. Patients may be excluded from the study based on these assessments (andspecifically if it is determined that their baseline health and psychiatric condition donot meet all pre-specified entry criteria).

Study Design

Total Participants: 396
Study Start date:
October 26, 2016
Estimated Completion Date:
June 25, 2019

Connect with a study center

  • Burgas, 8000
    Bulgaria

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  • Pazardzhik, 4400
    Bulgaria

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  • Plovdiv, 4000
    Bulgaria

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  • Sofia, 1408
    Bulgaria

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  • Targovishte, 7700
    Bulgaria

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  • Tserova Koria, 5047
    Bulgaria

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  • Varna, 9020
    Bulgaria

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  • Veliko Tarnovo, 5047
    Bulgaria

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  • Vratsa, 3000
    Bulgaria

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  • Chatham, Ontario N7L1C1
    Canada

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  • Montréal, Quebec H3A 1A1
    Canada

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  • Toronto, M6J 1H4
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  • Hradec Králové, 503 41
    Czechia

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  • Plzen, 312 00
    Czechia

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  • Praha 10, 100 00
    Czechia

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  • Praha 6, 160 00
    Czechia

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  • Říčany, 251 01
    Czechia

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  • Kalocsa, Bács-Kiskun Megya 6300
    Hungary

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  • Budapest, Pest Megye 1083
    Hungary

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    Gyula, 5700
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  • Pecs, 7633
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  • Kaunas, 44279
    Lithuania

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  • Silute, 99142
    Lithuania

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  • Vilnius, 09112
    Lithuania

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  • Białystok, 15 756
    Poland

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  • Bydgoszcz, 85 080
    Poland

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  • Lublin, 20 080
    Poland

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  • Pruszcz Gdański, 83 000
    Poland

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    Russian Federation

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    Roschino Poselok, Leningrad Region 188820
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    Russian Federation

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    Township Tonnelniy, Stavropol Region 357034
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    Ekaterinburg, 620030
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    Russian Federation

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    Russian Federation

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    Russian Federation

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    Russian Federation

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  • Smolensk, 214019
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  • Stavropol', 355038
    Russian Federation

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  • Voronezh, 394024
    Russian Federation

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  • Yaroslavl, 150003
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    Barcelona, 08830
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    Lviv, 79021
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    Odes'ka Obl., 67513
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  • Oleksandrivka, 67513
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  • Poltava, 36013
    Ukraine

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  • Smila, 08631
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  • Vinnytsia, 21005
    Ukraine

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    National City, California 91950
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    Oakland, California 94607
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  • Torrance, California 90502
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  • Boca Raton, Florida 33431
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    Bradenton, Florida 34201
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    Jacksonville, Florida 32256
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  • Lauderhill, Florida 33319
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  • Miami, Florida 33122
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    North Miami, Florida 33161
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    Orlando, Florida 32810
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    Tampa, Florida 33613
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  • Atlanta, Georgia 30331
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    Augusta, Georgia 30912
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    Decatur, Georgia 30030
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    Marietta, Georgia 30060
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  • Chicago, Illinois 60612
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  • Hoffman Estates, Illinois 60169
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  • Lake Charles, Louisiana 70629
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    Shreveport, Louisiana 71101
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  • Catonsville, Maryland 21228
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    Flowood, Mississippi 39232
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    Lincoln, Nebraska 68526
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  • Berlin, New Jersey 08009
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  • Cedarhurst, New York 11516
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  • Jamaica, New York 11432
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  • Rochester, New York 14618
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  • Charlotte, North Carolina 28211
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    Durham, North Carolina 27704
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  • Dayton, Ohio 45417
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    Oklahoma City, Oklahoma 73116
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  • Charleston, South Carolina 29407
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    Houston, Texas 77007
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  • Richardson, Texas 75080
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  • Salt Lake City, Utah 84105
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