Clinical trial NCT00725855: A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients
Official title: A Single-Center, Double-Blind, Placebo-Controlled, Randomized Blocks Study Investigating the Effect of 4 Dosages (1 mg, 5 mg, 15 mg, 50 mg) of MEM 3454 on P50 Sensory Gating and Mismatch Negativity (MMN) in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
P50 Sensory Gating
Mismatched Negativity
Lead sponsor: Memory Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2008-07-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio.

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.


Eligibility criteria: Inclusion Criteria:

* 1. Male or female subjects between 18and 55 years of age.
* 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:

* Current risk of suicide, or history of suicidal behavior within the last 6 months.
* 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.

Primary outcomes:
measure: Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454.
timeFrame: Pre-dosing and Day 1
Secondary outcomes:
measure: • Investigate the safety and tolerability of MEM 3454 compared with placebo
timeFrame: all time points
measure: • Determine whether MMN correlates with P50.
timeFrame: Pre-dose and day 1
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Ann Olincy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.