SchizophreniaPhase 4NCT00232349
Efficacy of Galantamine to Treat Schizophrenia
A Phase 4 study testing galantamine in people with Schizophrenia and Psychotic Disorder, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
The purpose of this study was to determine if treatment with adjunctive galantamine is effective in the reduction of functional impairments in patients with schizophrenia and schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorder
- What is being tested?
- galantamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jun 2007
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- Able to provide informed, written consent
- Treatment for schizophrenia or schizoaffective disorder for 5 or more years
- Diagnosis of schizophrenia or schizoaffective disorder
- Psychiatrically stable as evidenced by no hospitalizations and no changes in psychiatric medications (with the exception of dosage adjustments and the prescription of adjunctive treatments for sleep disturbance or anxiety) within the prior 3 months, and as confirmed by clinical interview during the screening phase
- Total score > 60 baseline on The Positive and Negative Syndrome Scale (PANSS)
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- Score > 3 on at least one of the five subscales of the SANS
- Non-Kraepelinian schizophrenia, as defined by the ability to independently provide for at least one domain of basic needs
- Females must be of non-child bearing potential or on appropriate contraceptive and not breast-feeding
- Females must have a negative serum beta HCG at screening
- Clinical laboratory values within normal limits, as defined in study protocol, or abnormalities considered not clinically significant by the investigator
Who cannot join
- Kraepelinian schizophrenia, as defined by dependency on others for the provision of all basic needs (including shopping, food preparation, household chores, and transportation);
- DSM-IV criteria for substance dependence (excluding nicotine and caffeine), as determined by SCID and chart review, during the 90 days prior to screening;
- Patients judged by the investigator as being at significant risk of suicide, violent behavior, or homicide;
- Concurrent participation or participation within the prior 30 days in any study involving investigational medications;
- Females who are pregnant or lactating;
- Neurodegenerative disorders such as Alzheimer's disease and other dementias, Parkinson's disease, Pick's disease, and Huntington's chorea;
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- A history of significant cerebrovascular event yielding a physical or neurological deficit likely to confound the assessment of the subject's functioning;
- A history of significant head trauma, defined as head trauma resulting in neurological or cognitive sequelae;
- A known personal history of seizure disorder;
- A known sensitivity to cholinesterase inhibitors, choline agonists, or similar agents;
- Patients who are known to be HIV positive;
- Evidence of clinically significant, active gastrointestinal, hepatic, pulmonary, endocrine, renal, or cardiovascular system disease;
- Active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g. inflammatory bowel disease or gastric or duodenal ulcers);
- Clinically significant urinary outflow obstruction;
- Patients with untreated thyroid disease;
- Patients with Type I or Type II diabetes controlled by medication or diet who do not have a HbA1c of < 8.5%;
- Patients with known significant cardiac history such as myocardial infarction or abnormal cardiac catheterization within the last 12 months.
- Unstable angina: angina or coronary artery disease requiring a change in medications within the 3 months prior to screening;
- Decompensated congestive heart failure;
- Severe mitral or aortic valvular disease;
- Atrial fibrillation;
- Greater than first degree atrioventricular block;
- QTc prolongation at screening;
- Bradycardia <50 beats/min;
- Current treatment with clozapine, olanzapine, chlorpromazine, or thioridazine;
- Use of potent cytochrome P450 inhibitors or inducers within 14 days before the Baseline Visit or during treatment, as listed in Appendix B of protocol;
- Current use of potent anticholinergic medication, as listed in Appendix B;
- Current use of any disallowed concomitant medication, as listed in Appendix B; and
- Any clinical finding that in the opinion of the investigator could potentially be negatively affected by study participation or that could potentially affect study participation is criterion for exclusion from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System, American Lake Division
Tacoma, Washington, 98493
About this study
Official title: An Open-Label Trial of Adjunctive Galantamine Maintenance Therapy to Treat Functional Impairments in Chronic Outpatients With Schizophrenia
The purpose of this study was to determine if treatment with adjunctive galantamine is effective in the reduction of functional impairments in patients with schizophrenia and schizoaffective disorder. It was hypothesized that adjunctive galantamine would yield clinically significant improvements from baseline to end of study on a measure of quality of life and a measure of independent living skills.
Read the detailed description
A majority of patients with schizophrenia or schizoaffective disorder experience impairments in social relations and employment. Many patients experience impairments in their ability to live independently, requiring assistance in such activities as money management, shopping, food preparation and hygiene. These impairments in functioning have been shown to be related to cognitive deficits associated with the disease.
Galantamine is a medication that has been approved by the FDA for the treatment of mild to moderate Alzheimer's disease. Both animal and human models have shown that galantamine can enhance learning and memory. Case reports and preliminary research have suggested that galantamine is an effective adjunctive treatment for schizophrenia, improving both cognition and negative symptoms. Improvements in functioning require that gains in cognition be maintained long enough to allow for the acquisition and application of new skills and behaviors.
Thus, this nine month, open label study assessed the efficacy of galantamine, dosed at 4-12 mg/twice a day, for the treatment of functional impairments in individuals, ages 18-60, with schizophrenia and schizoaffective disorder. The primary outcome measures were changes from baseline to end of study in scores on the Independent Living Scale (ILS) and the Quality of Life Scale (QLS). Secondary outcome measures included assessments of symptoms, cognition, side effects, and movement disorders.
Twenty-one subjects signed informed consent and fourteen subjects were initiated on medication. Six subjects completed the study. As per a priori plan, those subjects (n = 8) who were treated with study medication for at least four months were included in the analyses of treatment outcomes. Our findings regarding the efficacy of galantamine for functional outcomes, including activities of daily living and quality of life, did not support our hypothesis that long-term treatment with galantamine would yield improvements in these domains in patients with schizophrenia spectrum disorders. In fact, in the current study, we did not observe any anticipated improvements in cognition. In addition, we did not observe any anticipated improvements in symptoms, specifically negative symptoms.
- Conditions
- Schizophrenia, Psychotic Disorder
- Being tested
- galantamine
- Keywords
- schizophrenia, galantamine, cholinesterase inhibitors, quality of life, cognition
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galantamineDrug
Also called Razadyne, Reminyl
open label galantamine, dosed at 4-12 mg/b.i.d., with a target dose of 12 mg/b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | All subjects enrolled in study are in the intervention group. Receives: Drug: galantamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
score on a measure of quality of life
Measured: after 9 months treatment
score on a measure of independent living skills
Measured: after 9 months treatment
Secondary outcomes (3)
score on a measure of psychopathology
Measured: after 9 months treatment
score on a measure of negative symptoms
Measured: after 9 months treatment
score on a neurocognitive battery
Measured: after 9 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startFeb 2005
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Study terminated due to no apparent benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Investigators
- Andre Tapp, M.D., Principal investigator, VA Puget Sound Health Care System, Tacoma and Seattle, WA and University of Washington, Department of Psychiatry and Behavioral Sciences, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232349
- Sponsor's protocol ID
- TA1 28
- Other IDs
- GAL-EMR-4009
- Status last verified
- Jul 2008
- First submitted
- 30 Sep 2005
- Last updated
- 31 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Allen TB, McEvoy JP. Galantamine for treatment-resistant schizophrenia. Am J Psychiatry. 2002 Jul;159(7):1244-5. doi: 10.1176/appi.ajp.159.7.1244. No abstract available.
PubMed 12091212
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial of Adjunctive Galantamine Maintenance Therapy to Treat Functional Impairments in Chronic Outpatients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00232349
- Acronym / sponsor ID
- TA1 28
- Conditions
- Schizophrenia, Psychotic Disorder
- Keywords
- schizophrenia, galantamine, cholinesterase inhibitors, quality of life, cognition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to no apparent benefit.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 4 Oct 2005 (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 was to determine if treatment with adjunctive galantamine is effective in the reduction of functional impairments in patients with schizophrenia and schizoaffective disorder. It was hypothesized that adjunctive galantamine would yield clinically significant improvements from baseline to end of study on a measure of quality of life and a measure of independent living skills.
Detailed description
A majority of patients with schizophrenia or schizoaffective disorder experience impairments in social relations and employment. Many patients experience impairments in their ability to live independently, requiring assistance in such activities as money management, shopping, food preparation and hygiene. These impairments in functioning have been shown to be related to cognitive deficits associated with the disease.
Galantamine is a medication that has been approved by the FDA for the treatment of mild to moderate Alzheimer's disease. Both animal and human models have shown that galantamine can enhance learning and memory. Case reports and preliminary research have suggested that galantamine is an effective adjunctive treatment for schizophrenia, improving both cognition and negative symptoms. Improvements in functioning require that gains in cognition be maintained long enough to allow for the acquisition and application of new skills and behaviors.
Thus, this nine month, open label study assessed the efficacy of galantamine, dosed at 4-12 mg/twice a day, for the treatment of functional impairments in individuals, ages 18-60, with schizophrenia and schizoaffective disorder. The primary outcome measures were changes from baseline to end of study in scores on the Independent Living Scale (ILS) and the Quality of Life Scale (QLS). Secondary outcome measures included assessments of symptoms, cognition, side effects, and movement disorders.
Twenty-one subjects signed informed consent and fourteen subjects were initiated on medication. Six subjects completed the study. As per a priori plan, those subjects (n = 8) who were treated with study medication for at least four months were included in the analyses of treatment outcomes. Our findings regarding the efficacy of galantamine for functional outcomes, including activities of daily living and quality of life, did not support our hypothesis that long-term treatment with galantamine would yield improvements in these domains in patients with schizophrenia spectrum disorders. In fact, in the current study, we did not observe any anticipated improvements in cognition. In addition, we did not observe any anticipated improvements in symptoms, specifically negative symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: galantamineAll subjects enrolled in study are in the intervention group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 18-60
- Able to provide informed, written consent
- Treatment for schizophrenia or schizoaffective disorder for 5 or more years
- Diagnosis of schizophrenia or schizoaffective disorder
- Psychiatrically stable as evidenced by no hospitalizations and no changes in psychiatric medications (with the exception of dosage adjustments and the prescription of adjunctive treatments for sleep disturbance or anxiety) within the prior 3 months, and as confirmed by clinical interview during the screening phase
Key exclusion criteria (29 listed)
- Kraepelinian schizophrenia, as defined by dependency on others for the provision of all basic needs (including shopping, food preparation, household chores, and transportation);
- DSM-IV criteria for substance dependence (excluding nicotine and caffeine), as determined by SCID and chart review, during the 90 days prior to screening;
- Patients judged by the investigator as being at significant risk of suicide, violent behavior, or homicide;
- Concurrent participation or participation within the prior 30 days in any study involving investigational medications;
- Females who are pregnant or lactating;
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 |
|---|---|---|
| galantamineAlso: Razadyne, Reminylopen label galantamine, dosed at 4-12 mg/b.i.d., with a target dose of 12 mg/b.i.d. | Drug | Intervention group |
Primary outcome
score on a measure of quality of life
Time frame: after 9 months treatment
score on a measure of independent living skills
Time frame: after 9 months treatment
3 secondary outcomes
score on a measure of psychopathology
Time frame: after 9 months treatment
score on a measure of negative symptoms
Time frame: after 9 months treatment
score on a neurocognitive battery
Time frame: after 9 months treatment
Results and safety
The study was stopped early (reason given: Study terminated due to no apparent benefit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2008.
- Background: PubMed 12091212Allen TB, McEvoy JP. Galantamine for treatment-resistant schizophrenia. Am J Psychiatry. 2002 Jul;159(7):1244-5. doi: 10.1176/appi.ajp.159.7.1244. No abstract available.
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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.
Andre Tapp, M.D. principal investigator
VA Puget Sound Health Care System, Tacoma and Seattle, WA and University of Washington, Department of Psychiatry and Behavioral Sciences, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing galantamine in people with Schizophrenia and Psychotic Disorder, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
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 11 inclusion and 29 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: stopped early, as of the sponsor's last update on 31 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Study terminated due to no apparent benefit.). Results are not available in the source record.
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?
score on a measure of quality of life (time frame: after 9 months treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00232349, which also lists 1 linked publication.
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 31 Jul 2008.