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Effects of Galantamine on Cognition

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01100775
First Posted: April 9, 2010
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
L. Elliot Hong, University of Maryland
  Purpose
Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early twenties, with cognitive impairments and negative symptoms frequently emerging much earlier. Such cognitive impairments and negative symptoms but much milder are also observed in high-risk groups (such as relatives of schizophrenia patients), who may or may not develop the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test the effects of galantamine on clinical/physiological/cognitive measures. This study serves several goals: If a drug is found effective in treating subtle deficits, then it will provide treatment strategy in individuals with schizophrenia spectrum personality disorders and for early intervention in schizophrenia. In addition, one of the difficulties of testing a drug on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can change the effects of the test drug. The proposed study will be in subjects who will not be taking antipsychotic medications. Our study will be carried out in two sessions, at least one month apart. Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. We will administer a battery of clinical/cognitive/neurophysiological tests after the 8 mg drug dose.

Condition Intervention Phase
Schizophrenia Drug: Galantamine Drug: Galantamine or Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Effects of Galantamine on Cognition

Resource links provided by NLM:


Further study details as provided by L. Elliot Hong, University of Maryland:

Primary Outcome Measures:
  • Determine effect of drug on cognition [ Time Frame: 2 hours ]
    The study will test whether the drug improves cognition (such as memory and attention) within few hours of taking the drug)


Secondary Outcome Measures:
  • Determine the effect of the drug on ability to express or experience emotions [ Time Frame: 2 hours ]
    We will test the effects of the drug on negative symptoms that include difficulty experiencing or expressing emotions, decreased social drive and decreased motivation.


Estimated Enrollment: 24
Study Start Date: May 2010
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Galantamine
Drug: Galantamine
A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
Other Names:
  • Razadyne
  • 01RZ437
Placebo Comparator: Placebo
Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug.
Drug: Galantamine or Placebo
Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age range of 18-64 (confirmed by drivers license or other form of identification)
  • the presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
  • the presence of visuospatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
  • relative of an individual with schizophrenia, schizoaffective disorder, or schizophreniform disorder
  • able to provide written informed consent (ESC score 10 or above)

Exclusion Criteria:

  • subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
  • subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
  • medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
  • received any investigational drug in the preceding four weeks
  • pregnant or of childbearing age and not using a medically approved form of birth control
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100775


Locations
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: L. E. Hong, M.D. University of Maryland
  More Information

Responsible Party: L. Elliot Hong, L. Elliot Hong, M.D., University of Maryland
ClinicalTrials.gov Identifier: NCT01100775     History of Changes
Other Study ID Numbers: HP-00044959
1P50MH082999-01 ( U.S. NIH Grant/Contract )
First Submitted: January 4, 2010
First Posted: April 9, 2010
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by L. Elliot Hong, University of Maryland:
Galantamine
Schizophrenia
working memory
cognitive

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents