SchizophreniaPhase 2STAR-1NCT00509067
Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia
A Phase 2 study testing Galantamine, CDP-choline and risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole in people with Schizophrenia, run by Georgetown University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of galantamine and CDP-choline in improving symptoms associated with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Galantamine, CDP-choline and risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Eligible for care within the Veterans Affairs Medical system
- Taking risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole (oral or injection)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422
About this study
Official title: Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia
This study will evaluate the effectiveness of galantamine and CDP-choline in improving symptoms associated with schizophrenia.
Read the 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 16 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 15 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 14 weeks. Participants assigned to the control group will take two types of placebo pills every day for 16 weeks. All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole 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.
CDP-choline and matching placebos were purchased from LifeLink Corporation. Galantamine and matching placebos were prepared and donated by Ortho McNeil Janssen Scientific Affairs LLC.
- Conditions
- Schizophrenia
- Being tested
- Galantamine, CDP-choline, Placebo, risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole
- Keywords
- Schizoaffective Disorder, Acetylcholine, Nicotinic Receptors, Nicotine, Galantamine, negative symptoms
- 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
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.
CDP-cholineDrug
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.
PlaceboDrug
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.
risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazoleDrug
All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants assigned to receive galantamine and CDP-choline Receives: Drug: Galantamine; Drug: CDP-choline; Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole |
| B | Placebo comparator | Participants assigned to receive placebo Receives: Drug: Placebo; Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)
The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.
Measured: Measured at Baseline and Weeks 4, 8, 12, and 16
Secondary outcomes (2)
Clinical Global Impression
The score for each subject was the mean rating on the severity item. The score of the item ranged from 1 (normal) to 7 (among most severely ill).
Measured: Measured at Baseline and Weeks 4, 8, 12, and 16
MATRICS Verbal Learning and Memory
The measure of verbal learning and memory is the Hopkins Verbal Learning Test. The score for each subject is the sum of the total number of words recalled correctly for Trials 1, 2, and 3. The measure is the mean of these scores at baseline, Week 8, and Week 16.
Measured: Measured at Baseline and Weeks 8 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Washington D.C. Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Stephen I. Deutsch, National Institute of Mental Health (NIMH)
- Investigators
- Stephen I. Deutsch, PhD, MD, Principal investigator, Washington Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509067
- Sponsor's protocol ID
- R34MH077849
- Other IDs
- R34MH077849, DATR A5-ETBD
- Acronym
- STAR-1
- Status last verified
- Feb 2018
- First submitted
- 30 Jul 2007
- Last updated
- 11 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Deutsch SI, Schwartz BL, Schooler NR, Rosse RB, Mastropaolo J, Gaskins B. First administration of cytidine diphosphocholine and galantamine in schizophrenia: a sustained alpha7 nicotinic agonist strategy. Clin Neuropharmacol. 2008 Jan-Feb;31(1):34-9. doi: 10.1097/wnf.0b013e31806462ba.
PubMed 18303489Deutsch SI, Rosse RB, Schwartz BL, Schooler NR, Gaskins BL, Long KD, Mastropaolo J. Effects of CDP-choline and the combination of CDP-choline and galantamine differ in an animal model of schizophrenia: development of a selective alpha7 nicotinic acetylcholine receptor agonist strategy. Eur Neuropsychopharmacol. 2008 Feb;18(2):147-51. doi: 10.1016/j.euroneuro.2007.05.008. Epub 2007 Jul 26.
PubMed 17656074Martin LF, Freedman R. Schizophrenia and the alpha7 nicotinic acetylcholine receptor. Int Rev Neurobiol. 2007;78:225-46. doi: 10.1016/S0074-7742(06)78008-4.
PubMed 17349863Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.
PubMed 16754836
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia
- ClinicalTrials.gov ID
- NCT00509067
- Acronym / sponsor ID
- STAR-1 / R34MH077849
- Conditions
- Schizophrenia
- Keywords
- Schizoaffective Disorder, Acetylcholine, Nicotinic Receptors, Nicotine, Galantamine, negative symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Washington D.C. Veterans Affairs Medical Center
- Study start
- Nov 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Posted 7 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of galantamine and CDP-choline in improving symptoms associated with schizophrenia.
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 16 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 15 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 14 weeks. Participants assigned to the control group will take two types of placebo pills every day for 16 weeks. All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole 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.
CDP-choline and matching placebos were purchased from LifeLink Corporation. Galantamine and matching placebos were prepared and donated by Ortho McNeil Janssen Scientific Affairs LLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Galantamine, Drug: CDP-choline, Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazoleParticipants assigned to receive galantamine and CDP-choline |
| B | Placebo comparator | Drug: Placebo, Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazoleParticipants assigned to receive placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Eligible for care within the Veterans Affairs Medical system
- Taking risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole (oral or injection)
Key exclusion criteria (4 listed)
- 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
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: RazadyneGalantamine 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 | A |
| CDP-cholineCDP-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 | A |
| PlaceboThe 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 | B |
| risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazoleAll participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment. | Drug | A, B |
Primary outcome
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)
Time frame: Measured at Baseline and Weeks 4, 8, 12, and 16
The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.
2 secondary outcomes
Clinical Global Impression
Time frame: Measured at Baseline and Weeks 4, 8, 12, and 16
MATRICS Verbal Learning and Memory
Time frame: Measured at Baseline and Weeks 8 and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18303489Deutsch SI, Schwartz BL, Schooler NR, Rosse RB, Mastropaolo J, Gaskins B. First administration of cytidine diphosphocholine and galantamine in schizophrenia: a sustained alpha7 nicotinic agonist strategy. Clin Neuropharmacol. 2008 Jan-Feb;31(1):34-9. doi: 10.1097/wnf.0b013e31806462ba.
- Background: PubMed 17656074Deutsch SI, Rosse RB, Schwartz BL, Schooler NR, Gaskins BL, Long KD, Mastropaolo J. Effects of CDP-choline and the combination of CDP-choline and galantamine differ in an animal model of schizophrenia: development of a selective alpha7 nicotinic acetylcholine receptor agonist strategy. Eur Neuropsychopharmacol. 2008 Feb;18(2):147-51. doi: 10.1016/j.euroneuro.2007.05.008. Epub 2007 Jul 26.
- Background: PubMed 17349863Martin LF, Freedman R. Schizophrenia and the alpha7 nicotinic acetylcholine receptor. Int Rev Neurobiol. 2007;78:225-46. doi: 10.1016/S0074-7742(06)78008-4.
- Background: PubMed 16754836Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.
- Link for publication of study resultsLink 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.
Stephen I. Deutsch, PhD, MD principal investigator
Washington Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Galantamine, CDP-choline and risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole in people with Schizophrenia, run by Georgetown University 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 3 inclusion and 4 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 11 Apr 2018. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS) (time frame: Measured at Baseline and Weeks 4, 8, 12, and 16). 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 NCT00509067, which also lists 4 linked publications.
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 11 Apr 2018.