Clinical trial NCT01100775: Effects of Galantamine on Cognition
Official title: Effects of Galantamine on Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Galantamine
Schizophrenia
working memory
cognitive
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-04-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: RVIP Target Hit and False Alarm (Number of Responses)
timeFrame: 25 minutes (duration needed to complete this test)
measure: RVIP Reaction Times (ms)
timeFrame: 25 minutes (total duration to test RVIP)
measure: Trust Game (Dollar Amount Earned)
timeFrame: 20 minutes (total duration of the trust game cognitive test)
measure: Brief Assessment of Cognition for Schizophrenia (BACS) Score
timeFrame: 5 minutes (duration needed to complete the assessment)
measure: Hopkins Verbal Learning Test (HVLT) Score
timeFrame: 15 minutes (duration needed to complete this test)
measure: Reading the Mind in the Eyes Score (Number of Correct Responses)
timeFrame: 10 minutes (duration needed to complete the test)
measure: The Brief Smell Identification Test (B-SIT) Score (Number of Correct Responses)
timeFrame: 5 minutes (duration usually needed to complete this test)
Secondary outcomes:
measure: Social Affiliation Measured by Social Affiliative Role Play (Rating Scale Score)
timeFrame: 30 minutes (time needed to complete this test)
measure: Facial Affect Recognition Score (Number of Responses)
timeFrame: 10 minutes (time usually needed to complete this test)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: L. E. Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: