NCT00077727 is a Phase 3 clinical trial of Extended-release galantamine hydrobromide in Schizophrenia, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Who is sponsoring NCT00077727?

NCT00077727 is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

What drugs are being tested in NCT00077727?

Interventions in NCT00077727: Extended-release galantamine hydrobromide.

What condition does NCT00077727 study?

NCT00077727 studies Schizophrenia.

Is NCT00077727 still recruiting?

NCT00077727 is currently completed. Last updated 20 May 2011.

Last reviewed 2011-05-20 · How we verify

NCT00077727

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

A Study of Galantamine HBr as an Adjunctive Treatment to Atypical Antipsychotic Medications in Outpatients With Schizophrenia and Associated Cognitive Deficits.

Completed Phase 3 Last updated 20 May 2011

What this trial tests

Phase 3 trial testing Extended-release galantamine hydrobromide in Schizophrenia in 107 participants. Completed in 1 February 2005.

Timeline

1 March 2003

1 February 2005

Quick facts

Lead sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	107
Start date	1 March 2003
Estimated completion	1 February 2005

Drugs / interventions tested

Extended-release galantamine hydrobromide — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. — full company profile →

Who can join

Adults 18 to 55, 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.

The key exploratory efficacy end points are the change from baseline to Week 8 in total PANSS score, total BACS score, and CGI global improvement and severity of illness scores.

Sponsor's own description

The purpose of this study is to determine if adding extended-release galantamine hydrobromide, compared with adding placebo, to current atypical antipsychotic therapy is well tolerated and effective in improving cognitive impairment in patients with schizophrenia.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

The treatment of cognitive impairment in schizophrenia.
Goff DC, Hill M, Barch D. · · 2011 · cited 139× · PMID 21115035 · DOI 10.1016/j.pbb.2010.11.009
Acetylcholinesterase inhibitors for schizophrenia.
Singh J, Kour K, Jayaram MB. · · 2012 · cited 37× · PMID 22258978 · DOI 10.1002/14651858.cd007967.pub2
Ziprasidone versus other atypical antipsychotics for schizophrenia.
Komossa K, Rummel-Kluge C, Hunger H, Schwarz S, et al · · 2009 · cited 33× · PMID 19821380 · DOI 10.1002/14651858.cd006627.pub2
Pharmacological and Mechanistic Interventions for Cognitive Impairment Associated With Schizophrenia: A Review of Registered Clinical Trials.
Peyrovian B, Palaniyappan L, Kolivakis TT, Margolese HC. · · 2026 · PMID 40908273 · DOI 10.1111/acps.70034

Verify or expand the search:

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 Johnson & Johnson Pharmaceutical Research & Development, L.L.C. trials

Trials by the same sponsor.

NCT04330248 — A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants · Phase 1 · completed
NCT01094262 — A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthrit · Phase 2 · terminated
NCT01060254 — A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain · Phase 2 · terminated
NCT00973141 — A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis · Phase 2 · terminated
NCT01756404 — Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy · Phase 1 · completed

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 NCT00077727 (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 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last refreshed: 20 May 2011

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/NCT00077727.

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