NCT00968851

Brief Summary

This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Dec 2009

Geographic Reach
4 countries

31 active sites

Status
completed

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

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 25, 2014

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

August 28, 2009

Last Update Submit

March 28, 2014

Conditions

SchizophreniaCentral Nervous System DiseasesCognition

Keywords

SchizophreniaCentral nervous System DiseasesCognition

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function.

    84 days

Secondary Outcomes (1)

  • Assessment of Clinical Efficacy

    84 days

Study Arms (3)

EVP-6124 0.3 mg

ACTIVE COMPARATOR

one 0.3 mg capsule every day for 84 days

Drug: EVP-6124

EVP-6124 1.0 mg

ACTIVE COMPARATOR

one 1.0 mg capsule every day for 84 days.

Drug: EVP-6124

Placebo

PLACEBO COMPARATOR

Placebo every day for 84 days

Drug: Placebo

Interventions

EVP-6124DRUG

Arms: 1

EVP-6124 0.3 mg
PlaceboDRUG

Arm: 3

Placebo

Eligibility Criteria

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

You may qualify if:

  • Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI)
  • Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks
  • Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4
  • A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6
  • A minimal level of depression; Calgary Depression Scale total score ≤10
  • Must have a general health status acceptable for participation in a 12-week clinical trial
  • Fluency (oral and written) in the language in which the standardized tests will be administered
  • If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing

You may not qualify if:

  • General
  • Insufficiently controlled diabetes mellitus in the judgment of the investigator
  • Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ
  • Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
  • Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Intergrated Medical and Behavioral Associates

Glendale, California, 91204, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Affiliated Research Institute

San Diego, California, 92108, United States

Location

Schuster Medical Research Institute

Sherman Oaks, California, 91403, United States

Location

Scientific Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Alexian Brothers Behavioral Health

Hoffman Estates, Illinois, 60169, United States

Location

CBH Health, LLC

Rockville, Maryland, 20850, United States

Location

CRI Worldwide

Willingboro, New Jersey, 20850, United States

Location

Carolina Clinical Trials, Inc.

Charleston, South Carolina, 29407, United States

Location

Vanderbilt Psychiatric Hospital

Nashville, Tennessee, 37212-8645, United States

Location

FutureSearch Clinical Trials, L.P.

Austin, Texas, 78756, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Unknown Facility

Arkhangelsk, 163530, Russia

Location

Unknown Facility

Kazan', 420012, Russia

Location

Unknown Facility

Moscow, 107076, Russia

Location

Unknown Facility

Moscow, 115522, Russia

Location

Unknown Facility

Saint Petersburg, 190121, Russia

Location

Unknown Facility

Stavropol, 355108, Russia

Location

Clinical Site 1

Belgrade, 11000, Serbia

Location

Clinical Site 2

Belgrade, 11000, Serbia

Location

Clinical Site 3

Belgrade, 11000, Serbia

Location

Unknown Facility

Kragujevac, 34000, Serbia

Location

Unknown Facility

Niš, 18000, Serbia

Location

Unknown Facility

Crimea, 95006, Ukraine

Location

Unknown Facility

Dnipro, 49005, Ukraine

Location

Unknown Facility

Kiev, 02660, Ukraine

Location

Unknown Facility

Kiev, 04080, Ukraine

Location

Unknown Facility

Odesa, 65014, Ukraine

Location

Unknown Facility

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

  • Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

    PMID: 28433500DERIVED

MeSH Terms

Conditions

SchizophreniaCentral Nervous System Diseases

Interventions

7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNervous System Diseases

Study Officials

  • Chris Southard

    Syneos Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

April 25, 2014

Record last verified: 2012-03

Locations

RU(6)SE(5)UA(6)US(14)