NCT00725855

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 31, 2008

Status Verified

July 1, 2008

Enrollment Period

7 months

First QC Date

July 29, 2008

Last Update Submit

July 30, 2008

Conditions

Schizophrenia

Keywords

SchizophreniaP50 Sensory GatingMismatched Negativity

Outcome Measures

Primary Outcomes (1)

  • Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454.

    Pre-dosing and Day 1

Secondary Outcomes (2)

  • • Investigate the safety and tolerability of MEM 3454 compared with placebo

    all time points

  • • Determine whether MMN correlates with P50.

    Pre-dose and day 1

Study Arms (5)

1

EXPERIMENTAL

1 mg dose

Drug: MEM 3454

2

EXPERIMENTAL

5 mg dose

Drug: MEM 3454

3

EXPERIMENTAL

15 mg dose

Drug: MEM 3454

4

EXPERIMENTAL

50 mg dose

Drug: MEM 3454

5

PLACEBO COMPARATOR

Placebo dose

Drug: Placebo for MEM 3454

Interventions

MEM 3454DRUG

1 mg dose

1
Placebo for MEM 3454DRUG

Placebo dose

5

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Male or female subjects between 18and 55 years of age.
  • \. Fluent in English, even if English is not the primary language.
  • \. Able to provide informed consent.
  • \. DSM IV-R primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (SCID CT).
  • \. Few or no extra-pyramidal symptoms(EPS)at screening,defined as SAS \< 6.
  • \. Negative urine drug screen (UDS).
  • \. Negative cotinine test.
  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Related Publications (3)

  • 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.

    PMID: 17161386BACKGROUND

  • 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.

    PMID: 16754836BACKGROUND

  • 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.

    PMID: 12769624BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Ann Olincy, MD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Olincy, MD,

CONTACT

303-315-5046ann.olincy@uchsc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

July 31, 2008

Record last verified: 2008-07

Locations

US(1)