A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients (P50)
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEM 3454
MEM 3454
MEM 3454
MEM 3454
Placebo for MEM 3454
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, P50 Sensory Gating, Mismatched Negativity
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.
Sites / Locations
- University of Colorado Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
5
Arm Description
1 mg dose
5 mg dose
15 mg dose
50 mg dose
Placebo dose
Outcomes
Primary Outcome Measures
Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454.
Secondary Outcome Measures
• Investigate the safety and tolerability of MEM 3454 compared with placebo
• Determine whether MMN correlates with P50.
Full Information
NCT ID
NCT00725855
First Posted
July 29, 2008
Last Updated
July 30, 2008
Sponsor
Memory Pharmaceuticals
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00725855
Brief Title
A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients
Acronym
P50
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
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
April 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Memory Pharmaceuticals
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, P50 Sensory Gating, Mismatched Negativity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
1 mg dose
Arm Title
2
Arm Type
Experimental
Arm Description
5 mg dose
Arm Title
3
Arm Type
Experimental
Arm Description
15 mg dose
Arm Title
4
Arm Type
Experimental
Arm Description
50 mg dose
Arm Title
5
Arm Type
Placebo Comparator
Arm Description
Placebo dose
Intervention Type
Drug
Intervention Name(s)
MEM 3454
Intervention Description
1 mg dose
Intervention Type
Drug
Intervention Name(s)
MEM 3454
Intervention Description
5 mg dose
Intervention Type
Drug
Intervention Name(s)
MEM 3454
Intervention Description
15 mg dose
Intervention Type
Drug
Intervention Name(s)
MEM 3454
Intervention Description
50 mg dose
Intervention Type
Drug
Intervention Name(s)
Placebo for MEM 3454
Intervention Description
Placebo dose
Primary Outcome Measure Information:
Title
Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454.
Time Frame
Pre-dosing and Day 1
Secondary Outcome Measure Information:
Title
• Investigate the safety and tolerability of MEM 3454 compared with placebo
Time Frame
all time points
Title
• Determine whether MMN correlates with P50.
Time Frame
Pre-dose and day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Olincy, MD,
Phone
303-315-5046
Email
ann.olincy@uchsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Olincy, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Olincy, MD
Phone
303-315-5046
Email
ann.olincy@uchsc.edu
First Name & Middle Initial & Last Name & Degree
Ann Olincy, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
17161386
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.
Results Reference
background
PubMed Identifier
16754836
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.
Results Reference
background
PubMed Identifier
12769624
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.
Results Reference
background
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A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients
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