Effects of Galantamine on Cognition
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 3/6/2019 |
| Start Date: | May 2010 |
| End Date: | December 2019 |
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.
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.
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
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