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NCT01100775 · ClinicalTrials.gov registry record · Phase 2
Effects of Galantamine on Cognition
A Phase 2 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01100775 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 12 participants.
The verdict
NCT01100775, a Phase 2 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Galantamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-08-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01100775
The ClinicalTrials.gov registry entry for NCT01100775 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01100775 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01100775 about?
NCT01100775 is a clinical study titled "Effects of Galantamine on Cognition". 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 relati...
What is the current status of trial NCT01100775?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2010-05. Estimated completion is 2014-08-21.
What interventions are being tested in trial NCT01100775?
The interventions under investigation include: Placebo (DRUG), Galantamine (DRUG).
Who is sponsoring clinical trial NCT01100775?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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