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| ID | Type | Description | Link |
|---|---|---|---|
| GAL-EMR-4005 | Other Identifier | Janssen Pharmaceuticals |
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| Name | Class |
|---|---|
| Ortho-McNeil Janssen Scientific Affairs, LLC | INDUSTRY |
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The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ECT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2, Galantamine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Razadyne | Drug | The starting dose of study medication is 4 mg twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Side Effects | This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting. | Participants were followed for the duration of hospital stay, an average of 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Functioning | This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning. | Participants were questioned at baseline and after their last electroconvulsive therapy treatment |
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Inclusion Criteria:
Exclusion Criteria:
Note: Abstinence and the use of double barrier contraceptive methods are not acceptable in this study.
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| Name | Affiliation | Role |
|---|---|---|
| John D Matthews, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy. |
| FG001 | Galantamine | Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy. |
| BG001 | Galantamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Side Effects | This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting. | Posted | Number | Number of reported side effects | Participants were followed for the duration of hospital stay, an average of 3 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | General disorders | Systematic Assessment |
The limitations of this study include a small sample size, absence of an optimal galantamine dose determination, and the inclusion of a heterogenous population including MDD, bipolar disorder, and schizoaffective order.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Matthews | Massachusetts General Hospital | 617-724-0847 | jmatthews@partners.org |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
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| Placebo | Drug | 4 mg, 2 times a day |
|
| Baseline Depressive Symptoms | This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with <7 referring to mild-to-no depression, and >23 referring to severe depression. | Participants were questioned at baseline |
| Switched into a manic episode |
|
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Wechsler Abbreviated Scale of Intelligence (WASI) | The WASI is a standardized measurement of intelligence quotient (IQ). Scores range from 1 to 160, with 100 signifying average intelligence, scores above 140 signifying superior intelligence, and scores below 40 signifying severe intellectual impairment. | Mean | Standard Deviation | WASI Score |
|
| Hamilton Depression Rating Scale 17 (HAM-D-17) | This scale is a rater-administered assessment of depression severity and improvement. Scores range from 0 (not depressed) to 52 (severely depressed). | Mean | Standard Deviation | HAM-D-17 Score |
|
| Subjective Mood | Mean | Standard Deviation | Subjective Mood Score |
|
| Clinical-Global Impressions - Severity (CGI-S) | This scale is a rater-administered assessment of severity of symptoms. 1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients | Mean | Standard Deviation | CGI-S Score |
|
| Modified Mini Mental Status Exam (3MSE) | The 3MSE is a rater-administered test that assesses a broad variety of cognitive functioning. Scores range from 0 to 30. Scores greater than 25 indicate a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment. | Mean | Standard Deviation | 3MSE Score |
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| Secondary | Cognitive Functioning | This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning. | Posted | Mean | Standard Deviation | Score on the DMI | Participants were questioned at baseline and after their last electroconvulsive therapy treatment |
|
|
|
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| Secondary | Baseline Depressive Symptoms | This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with <7 referring to mild-to-no depression, and >23 referring to severe depression. | Posted | Mean | Standard Deviation | Score on the HAM-D-17 | Participants were questioned at baseline |
|
|
|
| 0 |
| 19 |
| 19 |
| 19 |
| EG001 | Galantamine | Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy. | 0 | 18 | 13 | 18 |
| headache | General disorders | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D019967 |
| Schizophrenia Spectrum and Other Psychotic Disorders |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |