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

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ClinicalTrials.gov Identifier: NCT02970305
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Pimavanserin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pimavanserin
Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
Drug: Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg, taken as two tablets, once daily by mouth
Placebo Comparator: Placebo
Placebo, taken as two tablets, once daily by mouth
Drug: Placebo
Placebo, taken as two tablets, once daily by mouth



Primary Outcome Measures :
  1. Change from Baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) total score [ Time Frame: 26 weeks ]
    Efficacy of pimavanserin compared with placebo in the adjunctive treatment of the negative symptoms of schizophrenia measured with Negative Symptom Assessment (NSA-16)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970305


Contacts
Contact: Ken Smith 609-250-6908 ksmith@acadia-pharm.com
Contact: Dragana Bugarski-Kirola, MD 609-250-6903 dbugarski-kirola@acadia-pharm.com

  Show 62 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02970305     History of Changes
Other Study ID Numbers: ACP-103-038
2016-003436-20 ( EudraCT Number )
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pimavanserin
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action