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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore