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| ID | Type | Description | Link |
|---|---|---|---|
| GSK110720 | |||
| IND 78,081 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label Lamotrigine Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine regular tablet formulation | Drug | Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) | Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed. | 12 weeks |
| Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, MD | Case Western Reserve University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Medical College of Cornell University | White Plains | New York | 10605 | United States | ||
| University Hospitals Case Medical Center/ Case Western Reserve University |
All subjects were required to have a score of 18 or higher on the Hamilton Rating Scale for Depression 24 to be included in the study.
Recruitment began in January 2008 and ended in December 2009. The study screened and enrolled participants at five academic institutions in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Lamotrigine Treatment | This solitary group received open-label lamotrigine treatment for bipolar depression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Lamotrigine Treatment | This solitary group received open-label lamotrigine treatment for bipolar depression. |
| 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 | Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment. | Posted | Aug 2011 | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.
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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 | Open-label Lamotrigine Treatment | This solitary group received open-label lamotrigine treatment for bipolar depression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Admission for Increased Anxiety | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight gain | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Bialko | Case Western Reserve University | 216-286-4362 | Christopher.Bialko@UHhospitals.org |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lamotrigine novel formulation | Drug | Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used. Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds. |
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|
The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition. |
| 12 weeks |
| Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS) | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | 12 weeks |
| Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. | 12 weeks |
| Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS) | The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition. | 12 weeks |
| Change in Body Weight From Baseline | 12 weeks |
| Number of Participants Who Fell at Least Once During the Study | 12 weeks |
| Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS) | The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition. | 12 weeks |
| Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS) | The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition. | 12 weeks |
| Number of Participants Who Had a Fall That Required Medical Attention | 12 weeks |
| Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine | 12 weeks |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor College of Medicine/Michael E. DeBakey VAMC | Houston | Texas | 77030 | United States |
| Lack of Efficacy |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) | Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed. | The number of participants was chosen from the number who received at least one dose of lamotrigine. | Posted | Aug 2011 | Number | participants | 12 weeks |
|
|
|
| Secondary | Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D) | The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition. | The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment. | Posted | Aug 2011 | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS) | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment. | Posted | Aug 2011 | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. | The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment. | Posted | Aug 2011 | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS) | The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition. | The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment. | Posted | Aug 2011 | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
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|
|
|
| Secondary | Change in Body Weight From Baseline | The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment. | Posted | Aug 2011 | Mean | 95% Confidence Interval | lbs. | 12 weeks |
|
|
|
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| Secondary | Number of Participants Who Fell at Least Once During the Study | The number of participants was chosen from the number who received at least one dose of lamotrigine. | Posted | Aug 2011 | Number | participants | 12 weeks |
|
|
|
| Secondary | Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS) | The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition. | The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment. | Posted | Aug 2011 | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS) | The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition. | The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment. | Posted | Aug 2011 | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
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| Secondary | Number of Participants Who Had a Fall That Required Medical Attention | The number of participants was chosen from the number who received at least one dose of lamotrigine. | Posted | Aug 2011 | Number | participants | 12 weeks |
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|
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| Secondary | Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine | The number of participants was chosen from the number who received at least one dose of lamotrigine. | Posted | Aug 2011 | Number | participants | 12 weeks |
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| 2 |
| 57 |
| 22 |
| 57 |
| Hospital Admission for Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
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| Weight Loss | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Increased Urinary Frequency | Renal and urinary disorders | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| polyuria/polydipsia |
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| weight gain |
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| increased sleep |
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| lassitude/fatigue |
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| unsteady gait |
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