SchizophreniaPhase 3NCT00077727
A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.
A Phase 3 study testing Extended-release galantamine hydrobromide in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Extended-release galantamine hydrobromide
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Feb 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia present for at least 1 year, and has not returned to his/her level of functioning before the disease, with a Brief Psychiatric Rating Scale score of 30 to 60 (inclusive), and cognitive impairment as determined by scores from neuropsychological tests and subtests
- Nicotine user with a minimum intake equivalent to 5 cigarettes per day
- On a stable dose of allowed atypical antipsychotic medication (risperidone [either oral or CONSTA], olanzapine, quetiapine, ziprasidone, or aripiprazole) alone or in combination, for at least 30 days before screening, and deemed able to continue on the same dose
- Women patients must be postmenopausal, surgically sterile, or using appropriate contraception before entry and throughout the study, and have a negative pregnancy test at screening
- Able to read, write, and understand English, and has no limitations in communication skills that would prevent him/her from completing the cognitive tests used in this study.
Who cannot join
- Previously enrolled in a galantamine hydrobromide study
- Any clinically significant uncontrolled medical illness (such as peptic ulcer disease
- urinary tract obstruction
- or neurologic, cardiac, hepatic, renal, metabolic, or endocrine disturbances)
- History of severe asthma
- Any history of epilepsy or convulsions, except for febrile convulsions during childhood
- History of cancer within the past year, except for treated basal cell carcinoma, or any history of prolactin-dependent breast cancer
About this study
Official title: A Study of Galantamine HBr as an Adjunctive Treatment to Atypical Antipsychotic Medications in Outpatients With Schizophrenia and Associated Cognitive Deficits.
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.
Read the detailed description
Galantamine acts on acetylcholinesterase, and has been shown to effectively treat cognitive symptoms in patients with Alzheimer's disease. Previous cellular research of nicotinic receptors has shown promising results, and it is theorized that the nicotinic system of patients with schizophrenia may be abnormal and may play an important role in the cognitive symptoms associated with schizophrenia. It is also postulated that galantamine may improve neuropsychiatric symptoms such as hallucinations, delusions, and apathy in patients with Alzheimer's disease. Atypical antipsychotic medications are effective treatment for schizophrenia patients but some symptoms remain. Therefore, galantamine may be a useful cotreatment for schizophrenia patients on atypical antipsychotic treatment. This is a pilot dose-ranging, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled multicenter study that examines the effects of taking extended-release galantamine hydrobromide (16 or 24 mg once daily) or placebo on the effectiveness in reducing symptoms of schizophrenia patients who are already taking an atypical antipsychotic medication. The safety of combined treatment is also examined. Measures of effectiveness include the Positive and Negative Syndrome Scale (PANSS) to measure neuropsychiatric symptoms of schizophrenia; the Clinical Global Impression (CGI) scale to measure change over the course of the study; the Brief Assessment of Cognition in Schizophrenia (BACS) for verbal memory and learning, working memory, motor function, attention, verbal fluency, and executive functioning; the Continuous Performance Test (CPT) for sustained attention and distractability; reaction time test (RTT) and finger tapping test (FTT) for psychomotor speed; Lexical and Semantic Fluency Test (LSFT) for language skills. As schizophrenia patients are a population with high nicotine use, and galantamine may act on nicotine receptors, blood levels of nicotine are also measured as varying nicotine levels could alter the effects of galantamine. The null hypothesis that there is no difference between the 2 groups (galantamine cotreatment and placebo) will be tested for each of the efficacy measurements (total PANSS, BACS, and CGI scores) at Week 8. Measures of safety include physical examinations, electrocardiograms (ECGs), clinical laboratory tests, measurement of plasma prolactin concentrations, pregnancy test for women, and incidence of adverse events. Adverse events that might be related to the medications are also monitored using the Simpson-Angus Extrapyramidal Side Effects Scale (SAS), the Barnes Akathisia Rating Scale (BARS), and the Abnormal Involuntary Movement Scale (AIMS). Extended-release galantamine hydrobromide or matching placebo capsules for once-daily dosing. Patients take 8 milligrams (mg) per day during Week 1, 16 mg per day during Week 2, and 16 mg or 24 mg per day (depending on randomization) during Weeks 3 to 8. Treatment groups are placebo capsule, 16 mg capsule, 24 mg capsule.
- Conditions
- Schizophrenia
- Being tested
- Extended-release galantamine hydrobromide
- Keywords
- Schizophrenia, cognitive impairment, galantamine, acetylcholinesterase inhibitors, antipsychotic drugs, BACS
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-release galantamine hydrobromideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (1)
Additional efficacy assessments included subscore analyses for LSFT, CPT, RTT and FTT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startMar 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077727
- Sponsor's protocol ID
- CR004366
- Status last verified
- Apr 2010
- First submitted
- 11 Feb 2004
- Last updated
- 24 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Galantamine HBr as an Adjunctive Treatment to Atypical Antipsychotic Medications in Outpatients With Schizophrenia and Associated Cognitive Deficits.
- ClinicalTrials.gov ID
- NCT00077727
- Acronym / sponsor ID
- CR004366
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, cognitive impairment, galantamine, acetylcholinesterase inhibitors, antipsychotic drugs, BACS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Feb 2005 (actual)
- First posted
- 16 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Galantamine acts on acetylcholinesterase, and has been shown to effectively treat cognitive symptoms in patients with Alzheimer's disease. Previous cellular research of nicotinic receptors has shown promising results, and it is theorized that the nicotinic system of patients with schizophrenia may be abnormal and may play an important role in the cognitive symptoms associated with schizophrenia. It is also postulated that galantamine may improve neuropsychiatric symptoms such as hallucinations, delusions, and apathy in patients with Alzheimer's disease. Atypical antipsychotic medications are effective treatment for schizophrenia patients but some symptoms remain. Therefore, galantamine may be a useful cotreatment for schizophrenia patients on atypical antipsychotic treatment. This is a pilot dose-ranging, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled multicenter study that examines the effects of taking extended-release galantamine hydrobromide (16 or 24 mg once daily) or placebo on the effectiveness in reducing symptoms of schizophrenia patients who are already taking an atypical antipsychotic medication. The safety of combined treatment is also examined. Measures of effectiveness include the Positive and Negative Syndrome Scale (PANSS) to measure neuropsychiatric symptoms of schizophrenia; the Clinical Global Impression (CGI) scale to measure change over the course of the study; the Brief Assessment of Cognition in Schizophrenia (BACS) for verbal memory and learning, working memory, motor function, attention, verbal fluency, and executive functioning; the Continuous Performance Test (CPT) for sustained attention and distractability; reaction time test (RTT) and finger tapping test (FTT) for psychomotor speed; Lexical and Semantic Fluency Test (LSFT) for language skills. As schizophrenia patients are a population with high nicotine use, and galantamine may act on nicotine receptors, blood levels of nicotine are also measured as varying nicotine levels could alter the effects of galantamine. The null hypothesis that there is no difference between the 2 groups (galantamine cotreatment and placebo) will be tested for each of the efficacy measurements (total PANSS, BACS, and CGI scores) at Week 8. Measures of safety include physical examinations, electrocardiograms (ECGs), clinical laboratory tests, measurement of plasma prolactin concentrations, pregnancy test for women, and incidence of adverse events. Adverse events that might be related to the medications are also monitored using the Simpson-Angus Extrapyramidal Side Effects Scale (SAS), the Barnes Akathisia Rating Scale (BARS), and the Abnormal Involuntary Movement Scale (AIMS). Extended-release galantamine hydrobromide or matching placebo capsules for once-daily dosing. Patients take 8 milligrams (mg) per day during Week 1, 16 mg per day during Week 2, and 16 mg or 24 mg per day (depending on randomization) during Weeks 3 to 8. Treatment groups are placebo capsule, 16 mg capsule, 24 mg capsule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia present for at least 1 year, and has not returned to his/her level of functioning before the disease, with a Brief Psychiatric Rating Scale score of 30 to 60 (inclusive), and cognitive impairment as determined by scores from neuropsychological tests and subtests
- Nicotine user with a minimum intake equivalent to 5 cigarettes per day
- On a stable dose of allowed atypical antipsychotic medication (risperidone [either oral or CONSTA], olanzapine, quetiapine, ziprasidone, or aripiprazole) alone or in combination, for at least 30 days before screening, and deemed able to continue on the same dose
- Women patients must be postmenopausal, surgically sterile, or using appropriate contraception before entry and throughout the study, and have a negative pregnancy test at screening
- Able to read, write, and understand English, and has no limitations in communication skills that would prevent him/her from completing the cognitive tests used in this study.
Key exclusion criteria (7 listed)
- Previously enrolled in a galantamine hydrobromide study
- Any clinically significant uncontrolled medical illness (such as peptic ulcer disease
- urinary tract obstruction
- or neurologic, cardiac, hepatic, renal, metabolic, or endocrine disturbances)
- History of severe asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended-release galantamine hydrobromide | Drug | – |
Primary outcome
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.
1 secondary outcome
Additional efficacy assessments included subscore analyses for LSFT, CPT, RTT and FTT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
- A study of the effectiveness and safety of galantamine hydrobromide on cognitive impairment in patients with schizophrenia.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extended-release galantamine hydrobromide in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2011.