A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00725855
• Other study ID #: MEM 3454-102
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 29, 2008
• Last updated: July 30, 2008
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2008
• Source: Memory Pharmaceuticals
• Contact: Ann Olincy, MD,
• Phone: 303-315-5046
• Email: ann.olincy[@]uchsc.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Memory Pharmaceuticals	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & 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. Epub 2006 Dec 8. — View 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. — View Citation

Simosky JK, Stevens KE, Freedman R. Nicotinic agonists and psychosis. Curr Drug Targets CNS Neurol Disord. 2002 Apr;1(2):149-62. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• Investigate the safety and tolerability of MEM 3454 compared with placebo		all time points	Yes
Secondary	• Determine whether MMN correlates with P50.		Pre-dose and day 1	No