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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of quetiapine SR monotherapy compared to divalproex sodium ER monotherapy in outpatient subjects with a lifetime bipolar I, II, or not otherwsise specified (NOS) disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 180 subjects will be randomized to obtain 90 subjects who complete the 8-week trial (30 completers per treatment group). This calculation is based on drop out rates in a similar patient population carried out by this group of collaborators. Subjects will be randomized to quetiapine SR or divalproex sodium ER or placebo in a 1:1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of extrapyramidal side effects (EPS). Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine SR | Active Comparator | Quetiapine SR (Quetiapine Sustained Release) |
|
| Divalproex Sodium ER | Active Comparator | Divalproex Sodium ER (Divalproex Sodium Extended Release) |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine SR | Drug | flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the CGI-21 Anxiety | The CGI-21 Anxiety is a 21-point clinician-rated global improvement for anxiety symptoms. Response range: -10 to +10. The higher the score the more improvement. At Baseline all patients have a score of "0" (zero), against which any subsequent improvements or deterioration is assessed. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANOVA. Outcomes showing scores above zero indicate that patients did better, i.e. showed improvement on this scale. | 8 weeks (using LOCF Repeated Measures ANOVA) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on Patient Global Improvement Scale (PGI-21) for Anxiety Symptoms | The PGI-21 Anxiety is a 21-point patient-rated global improvement for anxiety symptoms. Response range: -10 to +10. The higher the score the more improvement. At Baseline all patients have a score of "0" (zero), against which any subsequent improvements or deterioration is assessed. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANOVA. Outcomes showing scores above zero indicate that patients did better, i.e. showed improvement on this scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Sheehan, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto HCS & Stanford School of Medicine | Palo Alto | California | 94304 | United States | ||
| University of South Florida College of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine SR | Quetiapine SR (sustained release) |
| FG001 | Divalproex Sodium ER | Divalproex Sodium ER (extended release) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| divalproex sodium ER |
| Drug |
Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks |
|
| placebo | Drug | placebo |
|
| 8 weeks |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Hamilton Anxiety Scale (HAM-A) measures severity of anxiety symptoms - range of scores is 0-56. A higher score means worse anxiety. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (labeled "time") and treatment group (labeled "treatment") was the between-subjects factor with 3 levels. The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | 8 weeks |
| Change From Baseline in Sheehan Panic Disorder Scale (SPS) | Sheehan Panic Disorder Scale (SPS). Range of scores: 0-140. Higher scores indicate greater severity of symptoms. The relative efficacy of quetiapine SR vs. divalproex ER and placebo was tested using a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments for the efficacy variables were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The focus in this analysis was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in efficacy measures were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the baseline-to-endpoint LOCF ANCOVA. Outcome results with a "minus" indicate that patients did better, i.e. had a reduction in symptoms on this scale. | 8 weeks |
| Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) | Montgomery Asberg Depression Rating Scale (MADRS) measures severity of depressive symptoms. Range of scores: 0-60. A higher score shows greater severity of depressive symptoms. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The central focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in efficacy were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e had a reduction in symptoms on this scale. | 8 weeks |
| Change From Baseline in Young Mania Rating Scale (YMRS) | Young Mania Rating Scale (YMRS) measures severity of mania / hypomania symptoms. Range of scores: 0-60. A higher score shows worse mania / hypomania. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | 8 weeks |
| Change From Baseline on Clinician Global Impression Scale for Bipolar Disorder (CGI-BP) (Overall Severity) | Clinician Global Impression Scale for Bipolar Disorder (CGI-BP) measures the severity of bipolar disorder symptoms overall. Range of response: i1. normal, not ill to 7. very severely ill. A higher score represents greater severity. A last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels was used. The focus was on the "treatment-by-time" effect and whether the trajectory of response differed over time by treatment. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | 8 weeks |
| Change From Baseline on Rapid Ideas Scale (RISc) | Rapid ideas Scale (RISc) measures severity of rapid thoughts. Range of scores is 0-100. A higher score means more severe rapidity of thinking. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | 8 weeks |
| Change From Baseline in Sheehan Irritability Scale (SIS) | Sheehan Irritability Scale (SIS) measures severity of anxiety symptoms. Range of scores: 0-70. A higher score shows worse irritability. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | 8 weeks |
| Change From Baseline on Sheehan Disability Scale (SDS) - Total | Sheehan Disability Scale (SDS) measures severity of functional impairment or disability. There are 4 scores: 1) Work Disability 2) Social Disability 3) Family Life Disability. Each of these domains is scored 0-10, with a higher score representing greater disability or functional impairment. These 3 domain scores are added to give a Total Disability scale score. Range of response for Total Disability: 0 to 30. A higher score shows greater disability/functional impairment. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | 8 weeks |
| Change From Baseline on Sheehan- Suicidality Tracking Scale S-STS (2008 Version With 8 Items) | Sheehan - Suicidality Tracking Scale S-STS (2008 version with 8 items) measures severity of a range of suicidality symptoms. Range of scores: 0-32. A higher score represents more severe suicidality. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale.. | 8 weeks |
| Tampa |
| Florida |
| 33613 |
| United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| FG002 | Placebo | Placebo control |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine SR | Quetiapine SR (sustained release) |
| BG001 | Divalproex Sodium ER | Divalproex Sodium ER (extended release) |
| BG002 | Placebo | Placebo control |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Clinical Global Impression - Severity scale (CGI-S) | Among the most wide used brief assessments in psychiatry, the Clinical Global Impression - Severity scale (CGI-S) is a measure of symptom severity for patients with psychiatric disorders. The range of response is from 1 (normal) through 7 (among the most severely ill patients). A higher score indicates greater severity. Reference Clinical Global Impression (CGI) Reference: Guy W, editor. Early Clinical Drug Evaluation (ECDEU) Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare | Mean | Standard Deviation | units on a scale |
| |||||||||
| Hamilton Anxiety Scale (HAM-A) | Hamilton Anxiety Scale (HAM-A) measures severity of anxiety symptoms. The range of scores is 0-56. Higher scores indicate worse anxiety. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Sheehan Panic Disorder Scale (SPS) | Sheehan Panic Disorder Scale (SPS). The range of scores 0-140. A higher score indicates more severe symptoms of panic disorder. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Montgomery Asberg Depression Rating Scale (MADRS) | Montgomery Asberg Depression Rating Scale (MADRS) measures severity of depressive symptoms. The range of scores is 0-60. A higher score indicates worse depression. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Young Mania Rating Scale (YMRS) | Young Mania Rating Scale (YMRS) measures severity of mania / hypomania symptoms. The range of scores is 0-60. A higher score indicates worse mania / hypomania. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Sheehan Disability Scale (SDS) | Sheehan Disability Scale (SDS) measures severity of functional impairment or disability. There are 4 scores: 1) Work Disability 2) Social Disability 3) Family Life Disability. Each of these domains is scored 0-10, with a higher score representing greater disability or functional impairment. These 3 domain scores are added to give a Total Disability scale score. On total disability the score ranges from 0 to 30, with a higher score representing greater total disability or functional impairment. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Rapid Ideas Scale | Rapid ideas Scale (RISc) measures severity of rapid thoughts - range of scores 0-100 - the higher score represents more severe rapidity of thinking. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Sheehan Irritability Scale (SIS) | Sheehan Irritability Scale (SIS) measures severity of anxiety symptoms. The range of scores is 0-70. A higher score indicates worse irritability. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Suicidality Tracking Scale | Sheehan - Suicidality Tracking Scale (S-STS) (2008 version with 8 items) measures severity of a range of suicidality symptoms. Range of scores: 0-32. A higher score represents more severe suicidality. | This scale was only administered to the last 74 patients in the trial | Mean | Standard Deviation | units on a scale |
|
| 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 | Change From Baseline in the CGI-21 Anxiety | The CGI-21 Anxiety is a 21-point clinician-rated global improvement for anxiety symptoms. Response range: -10 to +10. The higher the score the more improvement. At Baseline all patients have a score of "0" (zero), against which any subsequent improvements or deterioration is assessed. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANOVA. Outcomes showing scores above zero indicate that patients did better, i.e. showed improvement on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks (using LOCF Repeated Measures ANOVA) |
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| Secondary | Change From Baseline on Patient Global Improvement Scale (PGI-21) for Anxiety Symptoms | The PGI-21 Anxiety is a 21-point patient-rated global improvement for anxiety symptoms. Response range: -10 to +10. The higher the score the more improvement. At Baseline all patients have a score of "0" (zero), against which any subsequent improvements or deterioration is assessed. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANOVA. Outcomes showing scores above zero indicate that patients did better, i.e. showed improvement on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Hamilton Anxiety Scale (HAM-A) measures severity of anxiety symptoms - range of scores is 0-56. A higher score means worse anxiety. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (labeled "time") and treatment group (labeled "treatment") was the between-subjects factor with 3 levels. The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline in Sheehan Panic Disorder Scale (SPS) | Sheehan Panic Disorder Scale (SPS). Range of scores: 0-140. Higher scores indicate greater severity of symptoms. The relative efficacy of quetiapine SR vs. divalproex ER and placebo was tested using a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments for the efficacy variables were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The focus in this analysis was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in efficacy measures were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the baseline-to-endpoint LOCF ANCOVA. Outcome results with a "minus" indicate that patients did better, i.e. had a reduction in symptoms on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) | Montgomery Asberg Depression Rating Scale (MADRS) measures severity of depressive symptoms. Range of scores: 0-60. A higher score shows greater severity of depressive symptoms. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The central focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in efficacy were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e had a reduction in symptoms on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline in Young Mania Rating Scale (YMRS) | Young Mania Rating Scale (YMRS) measures severity of mania / hypomania symptoms. Range of scores: 0-60. A higher score shows worse mania / hypomania. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline on Clinician Global Impression Scale for Bipolar Disorder (CGI-BP) (Overall Severity) | Clinician Global Impression Scale for Bipolar Disorder (CGI-BP) measures the severity of bipolar disorder symptoms overall. Range of response: i1. normal, not ill to 7. very severely ill. A higher score represents greater severity. A last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels was used. The focus was on the "treatment-by-time" effect and whether the trajectory of response differed over time by treatment. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline on Rapid Ideas Scale (RISc) | Rapid ideas Scale (RISc) measures severity of rapid thoughts. Range of scores is 0-100. A higher score means more severe rapidity of thinking. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | Posted | Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline in Sheehan Irritability Scale (SIS) | Sheehan Irritability Scale (SIS) measures severity of anxiety symptoms. Range of scores: 0-70. A higher score shows worse irritability. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. The focus was on the "treatment-by-time" effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline on Sheehan Disability Scale (SDS) - Total | Sheehan Disability Scale (SDS) measures severity of functional impairment or disability. There are 4 scores: 1) Work Disability 2) Social Disability 3) Family Life Disability. Each of these domains is scored 0-10, with a higher score representing greater disability or functional impairment. These 3 domain scores are added to give a Total Disability scale score. Range of response for Total Disability: 0 to 30. A higher score shows greater disability/functional impairment. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale. | Posted | Least Squares Mean | Standard Error | score on a scale | 8 weeks |
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| Secondary | Change From Baseline on Sheehan- Suicidality Tracking Scale S-STS (2008 Version With 8 Items) | Sheehan - Suicidality Tracking Scale S-STS (2008 version with 8 items) measures severity of a range of suicidality symptoms. Range of scores: 0-32. A higher score represents more severe suicidality. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors ("time") and treatment group ("treatment") was the between-subjects factor with 3 levels. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a "minus" score indicate that patients did better, i.e. had a reduction in symptoms on this scale.. | Only administered to the last 74 patients enrolled after November 2008 | Posted | Mean | Standard Error | score on a scale | 8 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 | Quetiapine SR | Quetiapine SR (sustained release) | 1 | 49 | 24 | 49 | ||
| EG001 | Divalproex Sodium ER | Divalproex Sodium ER (extended release) | 3 | 49 | 18 | 49 | ||
| EG002 | Placebo | Placebo control | 2 | 51 | 17 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fainted | Cardiac disorders | fainted | Systematic Assessment |
| |
| spider bite | Skin and subcutaneous tissue disorders | spider bite | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | back pain | Systematic Assessment |
| |
| worsening depression | Psychiatric disorders | worsening depression | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness/Sleepiness | Nervous system disorders | drowsiness | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | Dry Mouth | Systematic Assessment |
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| Nausea or Nausea/Vomiting | Gastrointestinal disorders | Nausea or Nausea/Vom | Systematic Assessment |
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| Tingling | Skin and subcutaneous tissue disorders | Tingling | Systematic Assessment |
| |
| Increased appetite | Gastrointestinal disorders | Increased appetite | Systematic Assessment |
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| Sedation | Nervous system disorders | Sedation | Systematic Assessment |
| |
| Headache | Nervous system disorders | Headache | Systematic Assessment |
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| Lightheadednessa | Nervous system disorders | Lightheadednessa | Systematic Assessment |
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| Tiredness | Nervous system disorders | Tiredness | Systematic Assessment |
| |
| Diarrheaa | Gastrointestinal disorders | Diarrheaa | Systematic Assessment |
| |
| Dizzinessa | Nervous system disorders | Dizzinessa | Systematic Assessment |
|
Study was limited to 8 weeks and to patients with bipolar disorder and comorbid panic disorder or generalized anxiety disorder.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David V. Sheehan, MD, MBA | University of South Florida College of Medicine | 813-974-4544 | dsheehan@health.usf.edu |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D016584 | Panic Disorder |
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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placebo placebo: placebo |
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| Placebo |
placebo placebo: placebo |
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| Placebo |
placebo placebo: placebo |
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| OG002 |
| Placebo |
placebo placebo: placebo |
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| Placebo |
placebo placebo: placebo |
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| OG002 | Placebo | placebo placebo: placebo |
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placebo placebo: placebo |
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| Placebo |
placebo placebo: placebo |
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| Placebo |
placebo placebo: placebo |
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| OG002 | Placebo | placebo placebo: placebo |
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