A Phase 4 interventional study of quetiapine SR and divalproex sodium ER in Bipolar Disorder, Panic Disorder and Generalized Anxiety Disorder, sponsored by University of South Florida. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by University of South Florida · Phase 4, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 224 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Quetiapine SR (Quetiapine Sustained Release)
Drug: quetiapine SR
Divalproex Sodium ER (Divalproex Sodium Extended Release)
Drug: divalproex sodium ER
placebo
Drug: placebo
flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks
Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks
placebo
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.
Time frame: 8 weeks (using LOCF Repeated Measures ANOVA)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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..
Time frame: 8 weeks
| Milestone | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Started | 49 | 49 | 51 |
| Completed | 47 | 46 | 51 |
| Not completed | 2 | 3 | 0 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline in the CGI-21 Anxiety | 4.9 ± 0.62 | 2.9 ± 0.63 | 3.4 ± 0.60 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline on Patient Global Improvement Scale (PGI-21) for Anxiety Symptoms | 3.9 ± 0.68 | 1.9 ± 0.69 | 2.3 ± 0.65 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | -11.7 ± 1.32 | -6.4 ± 1.30 | -8.4 ± 1.4 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline in Sheehan Panic Disorder Scale (SPS) | -24.4 ± 2.9 | -14.8 ± 2.9 | -18.3 ± 2.8 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) | -11.5 ± 1.5 | -5.5 ± 1.6 | -7.3 ± 1.5 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline in Young Mania Rating Scale (YMRS) | -5.4 ± 1.2 | -4.4 ± 1.2 | -4.3 ± 1.1 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline on Clinician Global Impression Scale for Bipolar Disorder (CGI-BP) (Overall Severity) | -1.2 ± .16 | -.5 ± .17 | -1.0 ± .16 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline on Rapid Ideas Scale (RISc) | -28.9 ± 3.4 | -19.7 ± 3.4 | -23.1 ± 3.3 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline in Sheehan Irritability Scale (SIS) | -29.8 ± 3.4 | -22.6 ± 3.4 | -19.4 ± 3.3 |
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.
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline on Sheehan Disability Scale (SDS) - Total | -6.5 ± 1.8 | -3 ± 1.2 | -5.3 ± 1.1 |
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..
| score on a scale | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Change From Baseline on Sheehan- Suicidality Tracking Scale S-STS (2008 Version With 8 Items) | -.95 ± .44 | -.07 ± .36 | -.3 ± .38 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quetiapine SR | — | 1/49 (2%) | 24/49 (49%) |
| Divalproex Sodium ER | — | 3/49 (6.1%) | 18/49 (36.7%) |
| Placebo | — | 2/51 (3.9%) | 17/51 (33.3%) |
| Event | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| faintedCardiac disorders | 0/49 | 1/49 | 0/51 |
| spider biteSkin and subcutaneous tissue disorders | 0/49 | 1/49 | 0/51 |
| worsening depressionPsychiatric disorders | 1/49 | 1/49 | 1/51 |
| back painMusculoskeletal and connective tissue disorders | 0/49 | 0/49 | 1/51 |
| Event | Quetiapine SR | Divalproex Sodium ER | Placebo |
|---|---|---|---|
| Drowsiness/SleepinessNervous system disorders | 24/49 | 18/49 | 17/51 |
| Dry MouthGastrointestinal disorders | 15/49 | 3/49 | 7/51 |
| Nausea or Nausea/VomitingGastrointestinal disorders | 9/49 | 12/49 | 14/51 |
| HeadacheNervous system disorders | 4/49 | 12/49 | 12/51 |
| TinglingSkin and subcutaneous tissue disorders | 8/49 | 1/49 | 1/51 |
| Increased appetiteGastrointestinal disorders | 7/49 | 6/49 | 7/51 |
| SedationNervous system disorders | 6/49 | 3/49 | 3/51 |
| LightheadednessaNervous system disorders | 4/49 | 2/49 | 1/51 |
| DiarrheaaGastrointestinal disorders | 1/49 | 2/49 | 4/51 |
| TirednessNervous system disorders | 3/49 | 1/49 | 3/51 |
| Age, Categorical(Participants) | Quetiapine SR | Divalproex Sodium ER | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 49 | 49 | 51 | 149 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Quetiapine SR | Divalproex Sodium ER | Placebo | Total |
|---|---|---|---|---|
| Mean | 41.4 ± 12.1 | 37.5 ± 12.0 | 37.6 ± 11.6 | 38.8 ± 12.0 |
| Sex: Female, Male(Participants) | Quetiapine SR | Divalproex Sodium ER | Placebo | Total |
|---|---|---|---|---|
| Female | 28 | 27 | 33 | 88 |
| Male | 21 | 22 | 18 | 61 |
| Region of Enrollment(participants) | Quetiapine SR | Divalproex Sodium ER | Placebo | Total |
|---|---|---|---|---|
| United States | 49 | 49 | 51 | 149 |
| Clinical Global Impression - Severity scale (CGI-S)(units on a scale) | Quetiapine SR | Divalproex Sodium ER | Placebo | Total |
|---|---|---|---|---|
| Mean | 5.4 ± .5 | 5.3 ± .6 | 5.4 ± .6 | 5.4 ± .6 |
| Hamilton Anxiety Scale (HAM-A)(units on a scale) | Quetiapine SR | Divalproex Sodium ER | Placebo | Total |
|---|---|---|---|---|
| Mean | 41.4 ± 12.1 | 37.5 ± 12.0 | 37.6 ± 11.6 | 38.8 ± 12.0 |
| Sheehan Panic Disorder Scale (SPS)(units on a scale) | Quetiapine SR | Divalproex Sodium ER | Placebo | Total |
|---|---|---|---|---|
| Mean | 47.5 ± 17.8 | 42.4 ± 18.5 | 41.8 ± 19.5 | 43.9 ± 18.7 |
| Montgomery Asberg Depression Rating Scale (MADRS)(units on a scale) | Quetiapine SR | Divalproex Sodium ER | Placebo | Total |
|---|---|---|---|---|
| Mean | 26.4 ± 8.3 | 24.5 ± 7.3 | 25.8 ± 7.9 | 25.6 ± 7.8 |
5 further baseline measures are reported on the registry.
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