Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia
NCT ID: NCT00825539
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
68 participants
INTERVENTIONAL
2009-01-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
AQW051
AQW051
Interventions
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AQW051
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Subjects will be currently treated with the stable regimen of one or more of the following second generation antipsychotics: olanzapine, risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
3. Subjects will meet the following symptom criteria:
* Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item scores less than or equal to 5
* BPRS Conceptual Disorganization item score less than or equal to 4
* Simpson-Angus Scale (SAS) total score less than or equal to 6
* Calgary Depression Scale (CDS) total score less than or equal to 10
4. Subjects will meet the following cognitive performance criteria:
* Maximum performance level: Performance below 1.0 SD from perfect performance on the Hopkins Verbal Learning Test (HVLT) total (31 or less),
* Minimum performance level: subject must be able to validly complete the fMRI cognitive paradigms
* WTAR: 5th grade reading level assessment
5. Subjects must be symptomatically stable and not suffer from an acute exacerbation of their psychosis
6. Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion. Pregnancy tests are required of all female subjects regardless of reported sterilization.
When performed at screening and practice visit, the result of this test must be received before the subject may be dosed.
7. Male subjects must be using two acceptable methods of contraception, (e.g., spermicidal gel plus condom) for the entire duration of the studyuntil the Study Completion visit.
8. Subject must have sufficiently stable overall health, as determined by the Investigator. The regular intake of concomitant drugs will be allowed, if the patient is on stable treatment for at least 3 months prior to study enrollment and the concomitant drug does not belong to the list of medication that are not allowed according to Appendix 3. If the patient takes more than one concomitant medication, it is at the Investigator's discretion to decide about the patient's eligibility, depending on the nature of the concomitant medications and the patient's overall health.
Exclusion Criteria
2. Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system
3. Subjects with a DSM-IV diagnosis of substance abuse (other than nicotine) within the last month.
4. Subjects with a history of significant head injury/trauma, as defined by:
* Loss of consciousness (LOC) for more than 1 hour
* Recurring seizures resulting from the head injury
* Clear cognitive sequelae of the injury
* Cognitive rehabilitation following the injury
5. Subjects with a medical or neurological disorder or treatment for such disorder that could interfere with the study medication of the assessment of the subject
6. Use of certain concomitant medication
No grapefruit or grapefruit juice is to be consumed for 14 days prior to dosing until 7 days following the last dose.
18 Years
60 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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West LA VA Healthcare Center (UCLA)
Los Angeles, California, United States
Department of Psychiatry & Behavioural Sciences, Feinberg School of Medicine (Northwestern University)
Chicago, Illinois, United States
Maryland Psychiatric Research Centre, Spring Grove Hospital Grounds
Baltimore, Maryland, United States
Massachusetts General Hospital (Freedom Trail Clinic)
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
JUH Clinical Research (Duke University),
Butner, North Carolina, United States
Countries
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References
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Barch DM, Marder SR, Harms MP, Jarskog LF, Buchanan RW, Cronenwett W, Chen LS, Weiss M, Maguire RP, Pezous N, Feuerbach D, Lopez-Lopez C, Johns DR, Behrje RB, Gomez-Mancilla B. Task-related fMRI responses to a nicotinic acetylcholine receptor partial agonist in schizophrenia: A randomized trial. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Nov 3;71:66-75. doi: 10.1016/j.pnpbp.2016.06.013. Epub 2016 Jun 28.
Related Links
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Results for CAQW051A2202 from the Novartis Clinical Trials website
Other Identifiers
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CAQW051A2202
Identifier Type: -
Identifier Source: org_study_id