A Phase 2 interventional study of Galantamine and Placebo in Schizophrenia, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-06-08.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Prevention
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.
3,471 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 12 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
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Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
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.
Drug: Galantamine · Drug: Placebo
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.
Drug: Galantamine · Drug: Placebo
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.
Also known as: Razadyne, 01RZ437
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes (duration usually needed to complete this test)
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)
Time frame: 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
Time frame: 10 minutes (time usually needed to complete this test)
| Milestone | Galantamine, Then Placebo | Placebo, Then Galantamine |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
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.
| Number of responses | Galantamine | Placebo |
|---|---|---|
| RVIP Practice Mean Target Hits | 23.4 ± 6.5 | 22.8 ± 7.47 |
| RVIP Practice Mean False Alarms | 19.7 ± 18.91 | 14.88 ± 18.12 |
| RVIP First Half Mean Target Hits | 25.4 ± 8.11 | 19.75 ± 5.42 |
| RVIP First Half Mean False Alarms | 20.7 ± 19.24 | 18.88 ± 26.49 |
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.
| milliseconds | Galantamine | Placebo |
|---|---|---|
| RVIP Practice Mean Target Reaction Time | 534.2 ± 63.3 | 581.5 ± 82.1 |
| RVIP Practice Mean False Alarm Reaction Time | 290.5 ± 67.5 | 380.5 ± 75.4 |
| RVIP First Half Mean Target Reaction Time | 525.1 ± 58.7 | 544 ± 105.6 |
| RVIP First Half Mean False Alarm Reaction Time | 215 ± 129 | 260 ± 104 |
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.
| Dollars | Galantamine | Placebo |
|---|---|---|
| Trust Game (Dollar Amount Earned) | 147.7 ± 81.1 | 131.4 ± 42.3 |
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.
| Number of correct responses | Galantamine | Placebo |
|---|---|---|
| Brief Assessment of Cognition for Schizophrenia (BACS) Score | 49 ± 9.82 | 52 ± 8 |
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.
| Number of correct responses | Galantamine | Placebo |
|---|---|---|
| HVLT Trial 1 | 7.7 ± 2.26 | 7.22 ± 1.99 |
| HVLT Trial 2 | 9.7 ± 1.77 | 10.22 ± 1.48 |
| HVLT Trial 3 | 10.8 ± 1.55 | 10.78 ± 1.3 |
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.
| Number of correct responses | Galantamine | Placebo |
|---|---|---|
| Reading the Mind in the Eyes Score (Number of Correct Responses) | 24.9 ± 5.26 | 24.12 ± 3.98 |
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.
| Number of correct responses | Galantamine | Placebo |
|---|---|---|
| The Brief Smell Identification Test (B-SIT) Score (Number of Correct Responses) | 10.2 ± 1.476 | 10.222 ± 0.833 |
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)
| units on a scale | Galantamine | Placebo |
|---|---|---|
| Overall Affect | 3.958 ± 0.68 | 3.8 ± 0.632 |
| Overall Social Skill | 4.15 ± 0.58 | 3.8 ± 0.715 |
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
| Number of Responses | Galantamine | Placebo |
|---|---|---|
| Facial Affect Total | 31.2 ± 4.49 | 33 ± 5.21 |
| Facial Affect Hits | 12.3 ± 7.07 | 14.38 ± 4.75 |
| Facial Affect False Alarms | 5.1 ± 4.46 | 5.38 ± 3.07 |
Collected over Collected over the course of 2 approximately 8 hour study days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Galantamine | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Placebo | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Event | Galantamine | Placebo |
|---|---|---|
| DizzinessGeneral disorders | 2/12 | 0/12 |
| InsomniaGeneral disorders | 2/12 | 0/12 |
| NauseaGeneral disorders | 2/12 | 0/12 |
| EuphoriaGeneral disorders | 1/12 | 0/12 |
| DrowsinessGeneral disorders | 1/12 | 0/12 |
| Blurred VisionGeneral disorders | 1/12 | 0/12 |
| Tearing of EyesGeneral disorders | 1/12 | 0/12 |
| HeadacheGeneral disorders | 1/12 | 1/12 |
| MalaiseGeneral disorders | 1/12 | 0/12 |
| SedationGeneral disorders | 1/12 | 0/12 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 53.33 ± 5.96 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 11 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 2 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 12 |
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University of Maryland, Baltimore