Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatments galantamine, galantamine or placebo
Phase phase 2
Sponsor University of Maryland
Collaborator National Institute of Mental Health (NIMH)
Start date May 2010
End date January 2017
Trial size 24 participants
Trial identifier NCT01100775, 1P50MH082999-01, HP-00044959

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
Arm
(Active Comparator)
Galantamine
galantamine Razadyne
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.
(Placebo Comparator)
Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug.
galantamine or placebo
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.

Primary Outcomes

Measure
Determine effect of drug on cognition
time frame: 2 hours

Secondary Outcomes

Measure
Determine the effect of the drug on ability to express or experience emotions
time frame: 2 hours

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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

Additional Information

Official title Effects of Galantamine on Cognition
Principal investigator L. E. Hong, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Maryland.