SchizophreniaPhase 2NCT01100775
Effects of Galantamine on Cognition
A Phase 2 study testing Galantamine in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early twenties, with cognitive impairments and negative symptoms frequently emerging much earlier. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Galantamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 21 Aug 2014
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age range of 18-64 (confirmed by drivers license or other form of identification)
- the presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
- the presence of visuospatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
- relative of an individual with schizophrenia, schizoaffective disorder, or schizophreniform disorder
- able to provide written informed consent (ESC score 10 or above)
Who cannot join
- subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
- subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
- medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
- received any investigational drug in the preceding four weeks
- pregnant or of childbearing age and not using a medically approved form of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21228
About this study
Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early twenties, with cognitive impairments and negative symptoms frequently emerging much earlier. Such cognitive impairments and negative symptoms but much milder are also observed in high-risk groups (such as relatives of schizophrenia patients), who may or may not develop the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test the effects of galantamine on clinical/physiological/cognitive measures. This study serves several goals: If a drug is found effective in treating subtle deficits, then it will provide treatment strategy in individuals with schizophrenia spectrum personality disorders and for early intervention in schizophrenia. In addition, one of the difficulties of testing a drug on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can change the effects of the test drug. The proposed study will be in subjects who will not be taking antipsychotic medications. Our study will be carried out in two sessions, at least one month apart. Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. We will administer a battery of clinical/cognitive/neurophysiological tests after the 8 mg drug dose.
- Conditions
- Schizophrenia
- Being tested
- Galantamine, Placebo
- Keywords
- Galantamine, Schizophrenia, working memory, cognitive
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalantamineDrug
Also called Razadyne, 01RZ437
A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
PlaceboDrug
Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
| Study group | Role | What they receive |
|---|---|---|
| Galantamine, then Placebo | Experimental | Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Receives: Drug: Galantamine; Drug: Placebo |
| Placebo, then Galantamine | Experimental | Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Receives: Drug: Galantamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RVIP Target Hit and False Alarm (Number of Responses)
Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits.
Measured: 25 minutes (duration needed to complete this test)
RVIP Reaction Times (ms)
Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits.
Measured: 25 minutes (total duration to test RVIP)
Trust Game (Dollar Amount Earned)
Participants compete in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds he participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive a portion of the toal offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240.
Measured: 20 minutes (total duration of the trust game cognitive test)
Brief Assessment of Cognition for Schizophrenia (BACS) Score
The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer adn provides a highly reliable measure of processing speed. There are nine symbols coded 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches in the participants score. Scores range from 0-110.
Measured: 5 minutes (duration needed to complete the assessment)
Hopkins Verbal Learning Test (HVLT) Score
HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials.
Measured: 15 minutes (duration needed to complete this test)
Reading the Mind in the Eyes Score (Number of Correct Responses)
A 30 item task presents a picture of a person's eyes and the participant is asked to determine the person's mental state from 4 multiple choice options.
Measured: 10 minutes (duration needed to complete the test)
The Brief Smell Identification Test (B-SIT) Score (Number of Correct Responses)
The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor.
Measured: 5 minutes (duration usually needed to complete this test)
Secondary outcomes (2)
Social Affiliation Measured by Social Affiliative Role Play (Rating Scale Score)
In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. participants are rated on a 5 point likert scale ranging from very poor (1) to very good (5)
Measured: 30 minutes (time needed to complete this test)
Facial Affect Recognition Score (Number of Responses)
This computer administered test includes 40 color photogralhs of four emotions (happy, sad, angry, and fearful) balanced for the posers gender, age and ethnicity, including four low intensity and four high intensity facila expressions of each emotion, plus 8 neutral faces. The stimuli are presented in random order and subjects are asked to identify which stimuli were presented to them at the end. Performance on this test correlates with negative symptom severity
Measured: 10 minutes (time usually needed to complete this test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMay 2010
- Primary completion21 Aug 2014
- Study completion21 Aug 2014
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.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, L. Elliot Hong, University of Maryland, Baltimore
- Investigators
- L. E. Hong, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100775
- Sponsor's protocol ID
- HP-00044959
- Other IDs
- 1P50MH082999-01
- Status last verified
- May 2022
- First submitted
- 4 Jan 2010
- Last updated
- 8 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Galantamine on Cognition
- ClinicalTrials.gov ID
- NCT01100775
- Acronym / sponsor ID
- HP-00044959
- Conditions
- Schizophrenia
- Keywords
- Galantamine, Schizophrenia, working memory, cognitive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2010
- Primary completion
- 21 Aug 2014 (actual)
- Study completion
- 21 Aug 2014 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Posted 8 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early twenties, with cognitive impairments and negative symptoms frequently emerging much earlier. Such cognitive impairments and negative symptoms but much milder are also observed in high-risk groups (such as relatives of schizophrenia patients), who may or may not develop the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test the effects of galantamine on clinical/physiological/cognitive measures. This study serves several goals: If a drug is found effective in treating subtle deficits, then it will provide treatment strategy in individuals with schizophrenia spectrum personality disorders and for early intervention in schizophrenia. In addition, one of the difficulties of testing a drug on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can change the effects of the test drug. The proposed study will be in subjects who will not be taking antipsychotic medications. Our study will be carried out in two sessions, at least one month apart. Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. We will administer a battery of clinical/cognitive/neurophysiological tests after the 8 mg drug dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galantamine, then Placebo | Experimental | Drug: Galantamine, Drug: PlaceboParticipants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. |
| Placebo, then Galantamine | Experimental | Drug: Galantamine, Drug: PlaceboParticipants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age range of 18-64 (confirmed by drivers license or other form of identification)
- the presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
- the presence of visuospatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
- relative of an individual with schizophrenia, schizoaffective disorder, or schizophreniform disorder
- able to provide written informed consent (ESC score 10 or above)
Key exclusion criteria (5 listed)
- subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
- subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
- medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
- received any investigational drug in the preceding four weeks
- pregnant or of childbearing age and not using a medically approved form of birth control
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, 01RZ437A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. | Drug | Galantamine, then Placebo, Placebo, then Galantamine |
| PlaceboSubjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. | Drug | Galantamine, then Placebo, Placebo, then Galantamine |
Primary outcome
RVIP Target Hit and False Alarm (Number of Responses)
Time frame: 25 minutes (duration needed to complete this test)
Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits.
RVIP Reaction Times (ms)
Time frame: 25 minutes (total duration to test RVIP)
Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits.
Trust Game (Dollar Amount Earned)
Time frame: 20 minutes (total duration of the trust game cognitive test)
Participants compete in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds he participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive a portion of the toal offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240.
Brief Assessment of Cognition for Schizophrenia (BACS) Score
Time frame: 5 minutes (duration needed to complete the assessment)
The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer adn provides a highly reliable measure of processing speed. There are nine symbols coded 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches in the participants score. Scores range from 0-110.
Hopkins Verbal Learning Test (HVLT) Score
Time frame: 15 minutes (duration needed to complete this test)
HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials.
Reading the Mind in the Eyes Score (Number of Correct Responses)
Time frame: 10 minutes (duration needed to complete the test)
A 30 item task presents a picture of a person's eyes and the participant is asked to determine the person's mental state from 4 multiple choice options.
The Brief Smell Identification Test (B-SIT) Score (Number of Correct Responses)
Time frame: 5 minutes (duration usually needed to complete this test)
The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor.
2 secondary outcomes
Social Affiliation Measured by Social Affiliative Role Play (Rating Scale Score)
Time frame: 30 minutes (time needed to complete this test)
Facial Affect Recognition Score (Number of Responses)
Time frame: 10 minutes (time usually needed to complete this test)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
L. E. Hong, M.D. principal investigator
University of Maryland, Baltimore
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 in people with Schizophrenia, run by University of Maryland, Baltimore 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 5 inclusion and 5 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 8 Jun 2022. 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 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 8 Jun 2022). 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?
RVIP Target Hit and False Alarm (Number of Responses) (time frame: 25 minutes (duration needed to complete this test)). The study lists 7 primary outcomes in all. 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 8 Jun 2022.