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AstraZeneca halted funding; patent expired for Seroquel (Quetiapine) in 2012
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The purpose of this study is to compare the efficacy and tolerability of Seroquel monotherapy for the treatment of Major Depression with Psychotic features with Seroquel plus Selective Serotonin Reuptake Inhibitor.
The proposed study is designed to investigate the non-inferiority of treatment of PsyD using monotherapy with quetiapine XR versus combination treatment using quetiapine XR and an SSRI (sertraline or citalopram or escitalopram) during the acute phase of treatment. The primary outcome measures will be the change rates of symptoms of depression (as measured on the Hamilton Rating Scale for Depression [HAM-D-17] and psychosis (as measured on the Brief Psychiatric Rating Scale [BPRS] Positive Symptoms Subscale).
The secondary aim of the study is to assess the safety and efficacy of the combination of quetiapine XR and SSRIs in patients with the diagnosis of PsyD. Metabolic factors including fasting glucose, fasting insulin, and fasting lipids (total cholesterol, HDL, LDL, and triglycerides) will be obtained at screen and at the 8-week endpoint of the study to assess the impact of treatment on the development of risk factors for metabolic syndrome. Measures of cognitive function (MGH Cognitive and Physical Functioning Questionnaire and RBANS) (Fava et al. 2006; Randolph et al. 1998) will be obtained at screen and the 8-week endpoint of the study to assess the impact of treatment on cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine | Experimental | Patients assigned to receive Quetiapine |
|
| Quetiapine and SSRI | Active Comparator | Patients assigned to receive Quetiapine and SSRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug | Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe. | 8 weeks |
| Psychosis | Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose | Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl. | 8 weeks |
| CPFQ (Cognitive and Psychological Functioning Questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy or lactation
Any DSM-IV Axis I disorder not defined in the inclusion criteria
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
Substance or alcohol dependence within the past three months (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
Involvement in the planning and conduct of the study
Previous enrolment or randomization of treatment in the present study.
Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
An absolute neutrophil count (ANC) of 1.5 x 10^9 per liter
Patients with a history seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
Patients who are currently treated with antidepressants other than the selective serotonin reuptake inhibitors, with mood stabilizing or antipsychotic drugs other than quetiapine.
Patients with known arrhythmias or arrhythmias noted on screening EKG.
Outpatients with a CGI score of 7.
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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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Participants were required to wash-out prior to randomization and study procedures. If the patient was unable to wash-out (by personal choice or doctor's recommendation), they were excluded. Seven subjects withdrew consent prior to randomization.
Participants were recruitment through newspaper advertisements in the Boston metro area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine | Patients assigned to receive Quetiapine •Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study. |
| FG001 | Quetiapine and SSRI | Patients assigned to receive Quetiapine and SSRI
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Thirty-two patients were consented and 25 participants were randomized. The remaining 7 participants withdrew consent prior to randomization and the collection of any baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine | Patients assigned to receive Quetiapine •Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Depression | Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
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 | Patients assigned to receive Quetiapine •Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute mania | Nervous system disorders | Systematic Assessment | The patient was hospitalized for acute mania and it was considered unrelated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Excess sedation | Psychiatric disorders | Systematic Assessment | Sedation is a common side effect from Seroquel |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D. Matthews, MD | Massachusetts General Hospital | 6177249144 | jdmatthews@partners.org |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D000089983 | Escitalopram |
| D020280 | Sertraline |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| escitalopram | Drug | Active comparator arm: Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m. |
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| Sertraline | Drug | Active comparator arm: Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m. Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m. Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m. |
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| Citalopram | Drug | Active comparator arm: Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m. |
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Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks.
| 8 weeks |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score | Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks. | 8 |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score | RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | 8 weeks |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale. | RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | 8 weeks |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score. | RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | 8 weeks |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8. | RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | 8 weeks |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8. | RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | 8 weeks |
| Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8. | Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl. | 8 weeks |
| Blood Level of Triglycerides at Baseline and Week 8. | Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl. | 8 weeks |
| HDL Blood Levels at Baseline and Week 8. | HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl. | 8 weeks |
| LDL Blood Levels at Baseline and Week 8. | LDL levels at Baseline and Week 8. Normal range < 100 mg/dl. | 8 weeks |
| Blood Hemoglobin A1C at Baseline and Week 8. | Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%. | 8 weeks |
| BG001 | Quetiapine and SSRI | Patients assigned to receive Quetiapine and SSRI
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Quetiapine With SSRI | Patients assigned to receive Quetiapine and SSRI
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| Primary | Psychosis | Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe. | Complete missing data for 2 subjects in the quetiapine with SSRI group (11 of 13 have baseline outcome measures). There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Fasting Blood Glucose | Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | ml/dl | 8 weeks |
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| Secondary | CPFQ (Cognitive and Psychological Functioning Questionnaire) | Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score | Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 |
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| Secondary | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score | RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale. | RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score. | RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8. | RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8. | RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8. | Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
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| Secondary | Blood Level of Triglycerides at Baseline and Week 8. | Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
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| Secondary | HDL Blood Levels at Baseline and Week 8. | HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
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| Secondary | LDL Blood Levels at Baseline and Week 8. | LDL levels at Baseline and Week 8. Normal range < 100 mg/dl. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
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| Secondary | Blood Hemoglobin A1C at Baseline and Week 8. | Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%. | Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group. | Posted | Mean | Standard Deviation | % glycated hemoglobin | 8 weeks |
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| 0 |
| 12 |
| 2 |
| 12 |
| 8 |
| 12 |
| EG001 | Quetiapine and SSRI | Patients assigned to receive Quetiapine and SSRI
| 0 | 13 | 1 | 13 | 10 | 13 |
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| Worsening depression | Psychiatric disorders | Systematic Assessment | Severity of depression resulted in psychiatric hospitalization. Considered to be unrelated to the study. |
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| Increased paranoia and auditory hallucinations | Psychiatric disorders | Systematic Assessment | The worsening psychosis resulted in psychiatric hospitalization. |
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| Leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fatigue | Nervous system disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dreaming | Psychiatric disorders | Systematic Assessment |
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| Headaches | Nervous system disorders | Systematic Assessment |
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| Light headedness | Cardiac disorders | Systematic Assessment |
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| Dry mouth | Nervous system disorders | Systematic Assessment |
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| Hand weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sweating | Nervous system disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Carbohydrate cravings | Nervous system disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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