Clinical Trial: A Study of Galantamine as an Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients with Cognitive Deficits

This study is currently recruiting patients.

Sponsored by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

This is an exploratory study which will evaluate Galantamine in cognitive deficits (learning) in patients with schizophrenia. The trial will last for 8 weeks. Efficacy and safety will be studied. The patients must be on a stable dose of an antipsychotic and smoke cigarettes.

Condition Treatment or Intervention Phase
Schizophrenia
 Drug: Galantamine ER
Phase II

MedlinePlus related topics:  Schizophrenia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Computerized Cognitve test battery
Expected Total Enrollment:  100

Study start: May 2003;  Expected completion: May 2005
Last follow-up: April 2005;  Data entry closure: May 2005

Eligibility

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

  • Patient must be on a stable atypical antipsychotic for at least 30 days
  • Women of child bearing potential must use approved method of birth control
  • Patients must smoke at least 5 cigarettes per day
  • Patient cannot have major medical problems

Location and Contact Information


Canada, Alberta
      Psychopharmcology Research Unit, Edmonton,  Alberta,  T6G 2B7,  Canada; Recruiting
Rawle Carter  780-407-1589 
Phillip Tibbo, MD,  Principal Investigator

      Foothills Medical Center, Calgary,  Alberta,  T2N T9,  Canada; Recruiting
Geri Anderson  403-944-1050 

Canada, Manitoba
      Health Sciences Center, Winnipeg,  Manitoba,  R3E 3N4,  Canada; Recruiting
Brendon Foot  204-787-3246 

Canada, Ontario
      Providence Continuing Care Center, Kingston,  Ontario,  K7L 4X3,  Canada; Recruiting
Ann Shea  613-548-5567  Ext. 5898 

      Royale Ottawa Hospital, Ottawa,  Ontario,  K17 7K4,  Canada; Recruiting
Sandhya Patel  613-722-6521  Ext. 6612 

More Information

Study ID Numbers:  GAL-SCH-201
Record last reviewed:  October 2004
Last Updated:  October 28, 2004
Record first received:  February 11, 2004
ClinicalTrials.gov Identifier:  NCT00077727
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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