Effects of Galantamine on Cognition
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Galantamine; Placebo
Intervention description: 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.; 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.
Intervention MeSH terms: Galantamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Galantamine; Schizophrenia; working memory; cognitive

Summary:

      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.
    

Eligibility 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