NCT00509067 (STAR-1) is a Phase 2 clinical trial of Galantamine in Schizophrenia, sponsored by Georgetown University.

Who is sponsoring NCT00509067?

NCT00509067 is sponsored by Georgetown University.

What drugs are being tested in NCT00509067?

Interventions in NCT00509067: Galantamine, CDP-choline, Placebo, risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole.

What condition does NCT00509067 study?

NCT00509067 studies Schizophrenia.

Is NCT00509067 still recruiting?

NCT00509067 is currently completed. Last updated 13 March 2018.

Are results published for NCT00509067?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-13 · How we verify

NCT00509067: STAR-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia

Completed Phase 2 Results posted Last updated 13 March 2018

What this trial tests

Phase 2 trial testing Galantamine in Schizophrenia in 43 participants. Completed in 1 March 2011.

Timeline

1 November 2007

Primary endpoint
1 March 2011

1 March 2011

Quick facts

Lead sponsor	Georgetown University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	43
Start date	1 November 2007
Primary completion	1 March 2011
Estimated completion	1 March 2011
Sites	1 location across United States

Drugs / interventions tested

Galantamine (GALANTAMINE) — full drug profile →
CDP-choline — full drug profile →
Placebo
risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Georgetown University

Who can join

Adults 18 to 70, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)
Time frame: Measured at Baseline and Weeks 4, 8, 12, and 16
The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratin

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Acetylcholinesterase inhibitors for schizophrenia.
Singh J, Kour K, Jayaram MB. · · 2012 · cited 37× · PMID 22258978 · DOI 10.1002/14651858.cd007967.pub2

Verify or expand the search:

Other trials of Galantamine

Trials testing the same drug.

NCT07003386 — Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke · Phase 2, PHASE3 · recruiting
NCT04769206 — Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans · Phase 1, PHASE2 · active not recruiting
NCT03384784 — Effect of Galantamine on Inflammation and Cognition · Phase 2 · completed
NCT01677754 — A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy · Phase 2 · completed

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Georgetown University trials

Trials by the same sponsor.

NCT07228000 — Bundled Cancer Screening and Genetic Services Navigation · NA · not yet recruiting
NCT07128927 — Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors · NA · recruiting
NCT06046287 — Daratumumab for Polyneuropathy Associated With MGUS · Phase 2 · withdrawn
NCT06980103 — Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyro · NA · recruiting
NCT07105358 — Visual Plasticity Following Brain Lesions · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00509067 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Georgetown University
Last refreshed: 13 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00509067.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing