Conditions: Schizophrenia
Keywords: Galantamine Schizophrenia working memory cognitive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. arm 2: Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.

Interventions: intervention 1: Galantamine intervention 2: Placebo
Intervention descriptions: intervention 1: 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 2: 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.

Protocol document: