A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients
NCT ID: NCT00725855
Last Updated: 2008-07-31
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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UNKNOWN
PHASE2
12 participants
INTERVENTIONAL
2008-08-31
2009-04-30
Brief Summary
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Data produced in this study will provide useful information regarding the value of P50 as an efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional P50 studies.
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
TRIPLE
Study Groups
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1
1 mg dose
MEM 3454
1 mg dose
2
5 mg dose
MEM 3454
5 mg dose
3
15 mg dose
MEM 3454
15 mg dose
4
50 mg dose
MEM 3454
50 mg dose
5
Placebo dose
Placebo for MEM 3454
Placebo dose
Interventions
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MEM 3454
1 mg dose
MEM 3454
5 mg dose
MEM 3454
15 mg dose
MEM 3454
50 mg dose
Placebo for MEM 3454
Placebo dose
Eligibility Criteria
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Inclusion Criteria
* 2\. Fluent in English, even if English is not the primary language.
* 3\. Able to provide informed consent.
* 4\. DSM IV-R primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (SCID CT).
* 5\. Few or no extra-pyramidal symptoms(EPS)at screening,defined as SAS \< 6.
* 6\. Negative urine drug screen (UDS).
* 7\. Negative cotinine test.
* 8\. Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. At least one month on the same dose of antipsychotic medication.
Exclusion Criteria
* Hospitalized for psychiatric symptoms in the past 3 months.
* Other psychiatric diagnoses.
* Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according to the SCID-CT.
* Currently smoking, nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).
* Any medical condition, as judged by the Investigator, which may interfere with the subjects' participation in this study.
18 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Memory Pharmaceuticals
INDUSTRY
Responsible Party
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Memory Pharmaceuticals Corp.
Principal Investigators
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Ann Olincy, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Health Sciences Center
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Ann Olincy, MD
Role: primary
References
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Braff DL, Light GA, Swerdlow NR. Prepulse inhibition and P50 suppression are both deficient but not correlated in schizophrenia patients. Biol Psychiatry. 2007 May 15;61(10):1204-7. doi: 10.1016/j.biopsych.2006.08.015. Epub 2006 Dec 8.
Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.
Simosky JK, Stevens KE, Freedman R. Nicotinic agonists and psychosis. Curr Drug Targets CNS Neurol Disord. 2002 Apr;1(2):149-62. doi: 10.2174/1568007024606168.
Other Identifiers
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MEM 3454-102
Identifier Type: -
Identifier Source: org_study_id