CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Galantamine +3 moredrug
Likely dose
Galantamine 24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00509067
NCT00509067Phase 2Completed
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Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia

Georgetown University·interventional·Posted Jul 31, 2007·Updated Apr 11, 2018

In Brief

A Phase 2 clinical trial evaluating Galantamine, CDP-choline, and 2 other interventions for Schizophrenia. Completed, enrolled 43 participants across 1 site.

Detailed Summary

This study will evaluate the effectiveness of galantamine and CDP-choline in improving symptoms associated with schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Washington D.C. Veterans Affairs Medical Center

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 31, 2007
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.9 years ago

Interventions

Galantaminedrug

Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.

CDP-cholinedrug

CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.

Placebodrug

The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.

risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazoledrug

All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.