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The Use of Galantamine and CDP-Choline to Treat Adults With Schizophrenia (STAR-1)

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00509067
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Galantamine
Drug: CDP-choline
Drug: Placebo
Drug: Risperidone
Phase II

MedlinePlus related topics:   Schizophrenia   

ChemIDplus related topics:   Risperidone    Galantamine hydrobromide    Galantamine    Acetylcholine    Acetylcholine chloride    Nicotine polacrilex    Nicotine tartrate    Cytidine diphosphate choline    Choline    Choline bitartrate    Choline chloride    Choline dihydrogen citrate    Choline salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Negative symptoms measured on Positive and Negative Syndrome Scale [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Cognitive measures (MATRICS: attention, memory, processing speed) [ Time Frame: Measured at Baseline and Weeks 8 and 16 ] [ Designated as safety issue: No ]
  • Nicotine use [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Electrocardiogram [ Time Frame: Measured at pre- and post-intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   50
Study Start Date:   November 2007
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Participants assigned to receive galantamine and CDP-choline
Drug: Galantamine
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.
Drug: CDP-choline
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.
Drug: Risperidone
All participants will continue to take their regular regimen of risperidone throughout the trial in addition to their assigned treatment.
B: Placebo Comparator
Participants assigned to receive placebo
Drug: Placebo
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.
Drug: Risperidone
All participants will continue to take their regular regimen of risperidone throughout the trial in addition to their assigned treatment.

Detailed Description:

Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, believe that others are controlling their thoughts, and even fail at maintaining a job or caring for themselves. Current medications help to relieve most of these negative symptoms, but not all. Many people with schizophrenia still suffer from low energy levels, an inability to concentrate, and memory loss. Galantamine is a medication that is used to improve memory and energy levels in people with Alzheimer's disease, and CDP-choline is a nutritional supplement. The purpose of this study is to evaluate the effectiveness of adding galantamine and CDP-choline to a stable anti-psychotic medication regimen of risperidone as a way of improving symptoms in adults with schizophrenia.

Participants in this double-blind study will attend an initial screening during which they will undergo a physical exam, an electrocardiogram, and blood and urine collection. Participants will then be randomly assigned to receive galantamine and CDP-choline or a placebo treatment for 17 weeks. Participants assigned to the treatment group will take 500 mg of CDP-choline daily for the first 3 days, 1,000 mg daily for the next 4 days, and 2,000 mg daily for the following 16 weeks. Participants assigned to the treatment group will also take 8 mg of galantamine daily for the first week, 16 mg daily for the next week, and 24 mg daily for the following 15 weeks. Participants assigned to the control group will take two placebo pills every day for 17 weeks. All participants will continue to take their regular regimen of risperidone throughout the trial in addition to their assigned treatment. Staff members will meet with participants during the first week of the study and every 4 weeks afterward until study completion. During these meetings, participants will identify any side effects, report nicotine intake, breathe into a machine that measures the amount of nicotine in the body, and complete written and computerized tasks on concentration and memory. Each meeting may last up to 3 hours. On the last week of the study, blood and urine samples will be collected and an electrocardiogram will be administered. Results from this study will be used to evaluate whether CDP-choline and galantamine improve schizophrenia symptoms.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Eligible for care within the Veterans Affairs Medical system
  • Taking risperidone (oral or injection)

Exclusion Criteria:

  • Significant liver, kidney, lung, endocrine, active peptic ulcer, or cardiovascular disease
  • Seizure disorder and/or head injury
  • Substance use or abuse within 3 months of study entry
  • Pregnant
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509067

Contacts
Contact: Stephanie M Rosse, BS     202-745-8000 ext 6172     Stephanie.Rosse@va.gov    
Contact: Barbara L. Schwartz, PhD     202-745-8000 ext 7206     Barbara.Schwartz@va.gov    

Locations
United States, District of Columbia
Washington Veterans Affairs Medical Center     Recruiting
      Washington, District of Columbia, United States, 20422
      Contact: Stephanie M. Rosse, BS     202-745-8000 ext 6172     Stephanie.Rosse@va.gov    
      Contact: Barbara L. Schwartz, PhD     202-745-8000 ext 7206     Barbara.Schwartz@va.gov    
      Principal Investigator: Stephen I. Deutsch, PhD, MD            
      Sub-Investigator: Richard B. Rosse, MD            
      Sub-Investigator: Nina Schooler, PhD            
      Sub-Investigator: Barbara L. Schwartz, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Stephen I. Deutsch, PhD, MD     Washington Veterans Affairs Medical Center    
  More Information

Publications:

Responsible Party:   Georgetown University/ VA Medical Center, Washington DC ( Stephen I. Deutsch, MD, PhD/ ACOS for Mental Health Service )
Study ID Numbers:   1 R34 MH077849, DATR A5-ETBD
First Received:   July 30, 2007
Last Updated:   August 27, 2008
ClinicalTrials.gov Identifier:   NCT00509067
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):
schizoaffective disorder  
acetylcholine  
nicotinic receptors  
nicotine
galantamine
negative symptoms

Study placed in the following topic categories:
Nicotine polacrilex
Choline
Galantamine
Risperidone
Serotonin
Schizophrenia
Dopamine
Mental Disorders
Nicotine
Cytidine Diphosphate Choline
Psychotic Disorders
Acetylcholine
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Antimetabolites
Parasympathomimetics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Cholinergic Agents
Serotonin Antagonists
Therapeutic Uses
Nootropic Agents
Lipotropic Agents
Tranquilizing Agents
Antilipemic Agents
Gastrointestinal Agents
Central Nervous System Depressants
Enzyme Inhibitors
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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