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

This study is currently recruiting participants.
Verified April 2017 by ACADIA Pharmaceuticals Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02970305
First Posted: November 22, 2016
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
  Purpose
To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of the negative symptoms of schizophrenia

Condition Intervention Phase
Schizophrenia Drug: Pimavanserin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 380
Study Start Date: November 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults patients, aged 18 years and above
  2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year
  3. Has predominant negative symptoms according to predefined study criteria
  4. Has had equal to or less than 10 years of treatment with an antipsychotic
  5. The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:

    • Aripiprazole
    • Risperidone
    • Olanzapine
    • Lurasidone
    • Cariprazine
    • Brexpiprazole
    • Asenapine
    • Risperidone long-acting injection
    • Aripiprazole long-acting injectables:

      • Abilify Maintena®
      • Aristada®

Exclusion Criteria:

  1. Patient has a psychiatric disorder other than schizophrenia
  2. Patient has current evidence of a serious and/or unstable 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
  3. Patient has had a myocardial infarction in the last six months
  4. Patient has a 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).

  Contacts and Locations
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: Ashley Haley, MD 919-745-2680 Ashley.Haley2@INCResearch.com
Contact: Dragana Bugarski-Kirola, MD 609-250-6903 dbugarski-kirola@acadia-pharm.com

Locations
United States, California
Recruiting
Culver City, California, United States, 90230
Recruiting
Glendale, California, United States, 91206
Recruiting
Los Angeles, California, United States, 90024
Recruiting
National City, California, United States, 91950
Recruiting
Norwalk, California, United States, 90650
Recruiting
Oakland, California, United States, 94607
Recruiting
Torrance, California, United States, 90502
United States, Florida
Recruiting
Bradenton, Florida, United States, 34201
Recruiting
Hialeah, Florida, United States, 33016
Recruiting
Jacksonville, Florida, United States, 32256
United States, Georgia
Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60612
United States, Mississippi
Recruiting
Flowood, Mississippi, United States, 39232
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89102
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States, 28211
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States, 73116
United States, Texas
Recruiting
Irving, Texas, United States, 75062
Recruiting
Richardson, Texas, United States, 75080
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

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 Submitted: November 18, 2016
First Posted: November 22, 2016
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Pimavanserin
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