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Status:

WITHDRAWN

Org 24448 (Ampakine) for Cognitive Deficits in Schizophrenia

Lead Sponsor:

University of California, Los Angeles

Collaborating Sponsors:

University of Maryland

Washington University School of Medicine

Conditions:

Schizophrenia

Eligibility:

All Genders

18-55 years

Phase:

PHASE2

Brief Summary

The TURNS is a National Institute of Mental Health (NIMH) funded contract for the evaluation of new compounds for the treatment of cognitive impairments in schizophrenia (HHSN 27820044 1003C; P.I.: St...

Detailed Description

This study is an eight-week, randomized, placebo-controlled, parallel group, fixed dose trial comparing two doses of the alpha-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor positi...

Eligibility Criteria

Inclusion

  • Diagnosis: schizophrenia, any subtype (DSM-IV/DSM-IV-TR)
  • Age: 18-55 years
  • Gender: male or female
  • Capable of providing informed consent
  • Antipsychotic: aripiprazole, olanzapine, quetiapine, risperidone or ziprasidone.
  • Subjects must have been maintained on current psychotropic medications for 8 weeks and on current doses for 4 weeks.
  • Subjects must be clinically stable and in the residual (non-acute) phase of their illness for at least 12 weeks.
  • Symptom Ratings:
  • No more than a "moderate" severity rating on hallucinations and delusions (i.e., Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item score 4)
  • No more than a "moderate" severity rating on positive formal thought disorder (i.e., BPRS Conceptual Disorganization item score 4)
  • No more than "moderate" severity rating on negative symptoms (i.e., all Scale for the Assessment of Negative Symptoms global items 3)
  • A minimal level of extrapyramidal symptoms (i.e., Simpson-Angus Scale total score 6)
  • A minimal level of depressive symptoms (i.e., Calgary Depression Scale total score 10).
  • Cognitive Status:
  • Performance less than the maximum cutoff (in parentheses) for ONE of the following MCCB tests:
  • Letter-number span (.20)
  • Hopkins Verbal Learning Test (HVLT) total (.31) and
  • Continuous Performance Test- Identical Pairs (CPT) d-prime (.3.47)
  • Able to complete the baseline MCCB validly as assessed by Chief Neuropsychologist or neuropsychology tester
  • Raw score of 6 or greater on the WTAR

Exclusion

  • Concomitant medications are allowed except for:
  • Conventional antipsychotics and clozapine
  • Antipsychotic polypharmacy
  • Anticholinergic agents (including anticholinergic antidepressants)
  • Carbamazepine, phenytoin and lamotrigine
  • DSM-IV/DSM-IV-TR diagnosis of alcohol or substance abuse (other than nicotine) within the last 3 months or a DSM-IV/DSM-IV-TR diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
  • A history of significant head injury/trauma, as defined by:
  • Loss of consciousness (LOC) for more than 1 hour
  • Recurring seizures resulting from the head injury
  • Clear cognitive sequelae of the injury
  • Cognitive rehabilitation following the injury
  • History of seizures or abnormal EEG
  • Epileptogenic abnormalities on screening EEG
  • A baseline white blood count (WBC) less than 3500/mm3 or absolute neutrophil count (ANC) less than 2000/mm3
  • Serious medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation.
  • History of transient ischemic attack (TIA) or cerebral vascular accident (CVA)
  • History of neutropenia or medication-induced blood dyscrasia
  • Clinically-significant abnormalities on screening laboratory or EKG.
  • Untreated hyper- or hypothyroidism
  • Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
  • Unable to complete neuropsychological tests
  • Serious suicidal or homicidal risk within the past six months
  • Participation in a trial of another investigational agent within 2 months
  • Treatment with Electroconvulsive therapy (ECT) within 2 months

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00425815

Start Date

April 1 2009

End Date

April 1 2009

Last Update

February 9 2016

Active Locations (8)

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Page 1 of 2 (8 locations)

1

UCLA

Los Angeles, California, United States, 90073

2

Maryland Psychiatric Research Center

Catonsville, Maryland, United States, 21228

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

4

Harvard Medical School

Boston, Massachusetts, United States, 02215