Major Depressive Disorder With Psychotic Features
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGQuetiapine
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.
DRUGescitalopram
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.
DRUGSertraline
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.
DRUGCitalopram
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Diagnosis of Major Depressive Disorder with Psychotic Features by the DSM-IV 3. Females and Males between the ages of 18-85 years. 4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment 5. Able to understand and comply with the requirements of the study 6. Initial HAM-D-17 score of \> 16, both at the screen visit and at the baseline visit. 7. Participants must have an initial BPRS score of \> 25 and at least one of the following: \> 5 for item 1, \> 5 for item 5, \> 5 for item 8, \> 4 for item 9, \> 1 for item 10, \> 1 for item 11; these BPRS criteria msut be met both at the screen visit and at the baseline visit. 8. Participants must have an initial CGI score of \> 2, both at the screen visit and at the baseline visit.
Exclusion criteria
1. Pregnancy or lactation 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 4. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator 5. 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 6. 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 7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization 8. 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 9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 11. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator 12. Involvement in the planning and conduct of the study 13. Previous enrolment or randomization of treatment in the present study. 14. Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements 15. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: * Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) \> 8.5%. * Admitted to hospital for treatment of DM or DM related illness in past 12 weeks. * Not under physician care for DM. * Physician responsible for patient's DM care has not indicated that patient's DM is controlled. * Physician responsible for patient's DM care has not approved patient's participation in the study * Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks. * Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks 16. An absolute neutrophil count (ANC) of 1.5 x 10\^9 per liter 17. 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. 18. Patients who are currently treated with antidepressants other than the selective serotonin reuptake inhibitors, with mood stabilizing or antipsychotic drugs other than quetiapine. 19. Patients with known arrhythmias or arrhythmias noted on screening EKG. 20. Outpatients with a CGI score of 7.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 8 weeks | 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. |
| Psychosis | 8 weeks | Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score | 8 | 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. |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score | 8 weeks | 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. |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale. | 8 weeks | 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. |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score. | 8 weeks | 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. |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8. | 8 weeks | 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. |
| Fasting Blood Glucose | 8 weeks | Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl. |
| Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8. | 8 weeks | Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be \<200mg/dl. |
| Blood Level of Triglycerides at Baseline and Week 8. | 8 weeks | Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl. |
| HDL Blood Levels at Baseline and Week 8. | 8 weeks | HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl. |
| LDL Blood Levels at Baseline and Week 8. | 8 weeks | LDL levels at Baseline and Week 8. Normal range \< 100 mg/dl. |
| Blood Hemoglobin A1C at Baseline and Week 8. | 8 weeks | Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%. |
| RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8. | 8 weeks | 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. |
| CPFQ (Cognitive and Psychological Functioning Questionnaire) | 8 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruitment through newspaper advertisements in the Boston metro area.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Quetiapine and SSRI Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* 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. | 13 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 7 | 5 |
Baseline characteristics
| Characteristic | Quetiapine | Quetiapine and SSRI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 13 Participants | 25 Participants |
| Age, Continuous | 39.25 years | 42.85 years | 40.32 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 12 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 9 Participants | 8 Participants | 17 Participants |
| Region of Enrollment United States | 12 participants | 13 participants | 25 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 8 / 12 | 10 / 13 |
| serious Total, serious adverse events | 2 / 12 | 1 / 13 |
Outcome results
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | Depression | Baseline | 27 units on a scale | Standard Deviation 16.21 |
| Quetiapine | Depression | Last visit | 9.57 units on a scale | Standard Deviation 5.44 |
| Quetiapine With SSRI | Depression | Last visit | 10.14 units on a scale | Standard Deviation 8.4 |
| Quetiapine With SSRI | Depression | Baseline | 26.73 units on a scale | Standard Deviation 6.84 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | Psychosis | Last visit | 34.25 units on a scale | Standard Deviation 25.04 |
| Quetiapine | Psychosis | Baseline | 56.09 units on a scale | Standard Deviation 7.26 |
| Quetiapine With SSRI | Psychosis | Baseline | 60.45 units on a scale | Standard Deviation 16.49 |
| Quetiapine With SSRI | Psychosis | Last visit | 32.83 units on a scale | Standard Deviation 8.98 |
Secondary
Blood Hemoglobin A1C at Baseline and Week 8.
Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | Blood Hemoglobin A1C at Baseline and Week 8. | Baseline | 5.6 % glycated hemoglobin | Standard Deviation 0.5 |
| Quetiapine | Blood Hemoglobin A1C at Baseline and Week 8. | Week 8 | 5.4 % glycated hemoglobin | Standard Deviation 0.5 |
| Quetiapine With SSRI | Blood Hemoglobin A1C at Baseline and Week 8. | Baseline | 5.7 % glycated hemoglobin | Standard Deviation 0.5 |
| Quetiapine With SSRI | Blood Hemoglobin A1C at Baseline and Week 8. | Week 8 | 5.8 % glycated hemoglobin | Standard Deviation 0.3 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8. | Baseline | 184.2 mg/dl | Standard Deviation 34.4 |
| Quetiapine | Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8. | Week 8 | 188 mg/dl | Standard Deviation 2.2 |
| Quetiapine With SSRI | Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8. | Baseline | 171.8 mg/dl | Standard Deviation 38.8 |
| Quetiapine With SSRI | Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8. | Week 8 | 201.7 mg/dl | Standard Deviation 55.8 |
Secondary
Blood Level of Triglycerides at Baseline and Week 8.
Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | Blood Level of Triglycerides at Baseline and Week 8. | Baseline | 144.9 mg/dl | Standard Deviation 71.1 |
| Quetiapine | Blood Level of Triglycerides at Baseline and Week 8. | Week 8 | 170.6 mg/dl | Standard Deviation 125.2 |
| Quetiapine With SSRI | Blood Level of Triglycerides at Baseline and Week 8. | Baseline | 154.25 mg/dl | Standard Deviation 80.5 |
| Quetiapine With SSRI | Blood Level of Triglycerides at Baseline and Week 8. | Week 8 | 190.5 mg/dl | Standard Deviation 68.5 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | CPFQ (Cognitive and Psychological Functioning Questionnaire) | Baseline | 30.8 units on a scale | Standard Deviation 4.69 |
| Quetiapine | CPFQ (Cognitive and Psychological Functioning Questionnaire) | Last visit | 23.56 units on a scale | Standard Deviation 7.07 |
| Quetiapine With SSRI | CPFQ (Cognitive and Psychological Functioning Questionnaire) | Baseline | 29.3 units on a scale | Standard Deviation 9.24 |
| Quetiapine With SSRI | CPFQ (Cognitive and Psychological Functioning Questionnaire) | Last visit | 21.00 units on a scale | Standard Deviation 6.4 |
Secondary
Fasting Blood Glucose
Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | Fasting Blood Glucose | Baseline | 91.6 ml/dl | Standard Deviation 10.2 |
| Quetiapine | Fasting Blood Glucose | Week 8 | 89.1 ml/dl | Standard Deviation 2.2 |
| Quetiapine With SSRI | Fasting Blood Glucose | Baseline | 89.4 ml/dl | Standard Deviation 10.6 |
| Quetiapine With SSRI | Fasting Blood Glucose | Week 8 | 96.8 ml/dl | Standard Deviation 19.2 |
Secondary
HDL Blood Levels at Baseline and Week 8.
HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | HDL Blood Levels at Baseline and Week 8. | Baseline | 47.7 mg/dl | Standard Deviation 15.1 |
| Quetiapine | HDL Blood Levels at Baseline and Week 8. | Week 8 | 40.8 mg/dl | Standard Deviation 13.2 |
| Quetiapine With SSRI | HDL Blood Levels at Baseline and Week 8. | Baseline | 45.3 mg/dl | Standard Deviation 6.6 |
| Quetiapine With SSRI | HDL Blood Levels at Baseline and Week 8. | Week 8 | 40.5 mg/dl | Standard Deviation 12.2 |
Secondary
LDL Blood Levels at Baseline and Week 8.
LDL levels at Baseline and Week 8. Normal range \< 100 mg/dl.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | LDL Blood Levels at Baseline and Week 8. | Baseline | 109 mg/dl | Standard Deviation 25.3 |
| Quetiapine | LDL Blood Levels at Baseline and Week 8. | Week 8 | 121.1 mg/dl | Standard Deviation 39.4 |
| Quetiapine With SSRI | LDL Blood Levels at Baseline and Week 8. | Week 8 | 123.3 mg/dl | Standard Deviation 42.2 |
| Quetiapine With SSRI | LDL Blood Levels at Baseline and Week 8. | Baseline | 94.6 mg/dl | Standard Deviation 27.3 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8. | Baseline | 95.8 units on a scale | Standard Deviation 17.1 |
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8. | Week 8 | 104.6 units on a scale | Standard Deviation 21.6 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8. | Baseline | 85.4 units on a scale | Standard Deviation 15.9 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8. | Week 8 | 86.1 units on a scale | Standard Deviation 11 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8. | Baseline | 82.4 units on a scale | Standard Deviation 21.6 |
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8. | Week 8 | 72.9 units on a scale | Standard Deviation 13.7 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8. | Baseline | 69.6 units on a scale | Standard Deviation 22.3 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8. | Week 8 | 74.7 units on a scale | Standard Deviation 24.3 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score | Baseline | 83.3 units on a scale | Standard Deviation 17.2 |
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score | Week 8 | 82.8 units on a scale | Standard Deviation 14.4 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score | Baseline | 71.1 units on a scale | Standard Deviation 14.1 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score | Week 8 | 77.9 units on a scale | Standard Deviation 16.2 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score. | Baseline | 80.4 units on a scale | Standard Deviation 16.2 |
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score. | Week 8 | 87.9 units on a scale | Standard Deviation 13.7 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score. | Baseline | 77.6 units on a scale | Standard Deviation 21.2 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score. | Week 8 | 91.1 units on a scale | Standard Deviation 7.9 |
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.
Time frame: 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score | Baseline | 77.38 units on a scale | Standard Deviation 13.71 |
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score | Last visit | 77.25 units on a scale | Standard Deviation 15.23 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score | Baseline | 70.00 units on a scale | Standard Deviation 16.12 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score | Last visit | 78.29 units on a scale | Standard Deviation 16.94 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale. | Baseline | 70.6 units on a scale | Standard Deviation 15.9 |
| Quetiapine | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale. | Week 8 | 70.5 units on a scale | Standard Deviation 30.8 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale. | Baseline | 75.6 units on a scale | Standard Deviation 16.1 |
| Quetiapine With SSRI | RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale. | Week 8 | 78.3 units on a scale | Standard Deviation 17.8 |