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| ID | Type | Description | Link |
|---|---|---|---|
| 112006-017 |
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Enrollment discontinued based on mutually agreed upon decision by PI and funding sponsor
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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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Hypothesis I: Patients in the SSRI + ramelteon treatment group will achieve remission (defined as an IDS-C30 score of 11 or less) more quickly than those in the SSRI + placebo group.
The primary objective of the study is to assess the time to remission in depression with initial insomnia using the SSRI antidepressant escitalopram combined with ramelteon or placebo. Patients will be assessed at each visit for depressive symptoms and insomnia, using the 30-item Inventory of Depressive Symptoms, Clinician-Rated version (IDS-C30; Rush et al 1986; Rush et al., 1996) as the primary outcome measure. The IDS self-report version will be used to assess self-reported changes in symptom severity. The 17 item Hamilton Rating Scale for Depression, (HRSD17; Hamilton, 1960) will also be administered, as it is the most commonly utilized depression symptom severity measure at this time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Ramelteon (One 8 mg capsule at night) |
|
| 2 | Placebo Comparator | Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Matching Placebo (One capsule at night) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | Escitalopram 10 or 20mg qd based on symptoms at patient visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Remitters on IDS-C30 at Week 12 | Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Latency | Number of minutes until fell asleep | 12 weeks |
| Short-Form Health Survey - Version 2 (SF-36) | The Short-Form Health Survey - version 2 (SF-36) is a self-report inventory measuring different domains of health-related quality of life: Physical Functioning, Physical Role Functioning, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Functioning, and Mental Health. Scores range from 0 to 100, with higher scores indicating better perceived health and functioning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 752390-9119 | United States |
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| Label | URL |
|---|---|
| Mood Disorders Research Program and Clinic | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram + Ramelteon | active augmentation |
| FG001 | Escitalopram + Placebo | Placebo augmentation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram + Ramelteon | active augmentation |
| BG001 | Escitalopram + Placebo | Placebo augmentation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Remitters on IDS-C30 at Week 12 | Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity | Participants who were randomized to treatment and completed Week 12 were included in analyses | Posted | Number | percentage of participants | 12 Weeks |
|
During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
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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 | Escitalopram + Ramelteon | active augmentation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Prabha Sunderajan- Assistant Professor | UT Southwestern Medical Center | 214-645-6964 | psunderajan@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| C495910 | ramelteon |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Ramelteon | Drug | Ramelteon 8 mg qd |
|
|
| Placebo | Other | Matching placebo qd |
|
| 12 Weeks |
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) measures satisfaction and enjoyment in various domains of functioning: physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and ranges from 0 to 100. Higher scores indicate greater enjoyment and satisfaction. | 12 Weeks |
| Social Adjustment Scale - Self-Report (SAS-SR) | The Social Adjustment Scale - Self-Report (SAS-SR) is a 54-item self-report measure of instrumental and expressive role performance. Each item is rated on a 5-point scale, and a mean item score (ranging from 1-5) is obtained, with higher scores indicating greater impairment. | 12 Weeks |
| Work and Social Adjustment Scale (WSAS) | The Work and Social Adjustment Scale (WSAS) is 5-item self-report measure designed to identify functional impairment that is attributed to an identified problem or condition. and has been used in studies of depression and anxiety. Scores range between 0-40, with higher scores indicating worse functioning. | 12 Weeks |
| Work Productivity and Activity Impairment Questionnaire (WPAI) | The Work Productivity and Activity Impairment Questionnaire (WPAI) was used to report impairment while working or performing usual daily activities as a result of health problems. The activity impairment item (#6 of WPAI) is rated on a scale of 0-10, with higher scores indicating greater impairment. Scores are multiplied by 10 to obtain percent impairment. | 12 Weeks |
| Patient Perception of Benefits of Care (PPBC) | The Patient Perception of Benefits of Care (PPBC) assesses how much patients believe their quality of life will improve in response to medical care or treatment. Scores range between 10-50, with lower scores indicating greater belief that treatment will improve quality of life. | 12 Weeks |
| Hamilton Rating Scale for Depression 17-item | The Hamilton Rating Scale for Depression is a clinician-administered rating scale that assesses severity of depressive symptoms and is one of the most widely used and validated symptom severity measures for depression. Each of the 17 items is rated by the clinician on either a 3- or a 5 point scale. Total scores range from 0-52, with higher scores indicating greater depressive symptoms. | 12 Weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Sleep Latency | Number of minutes until fell asleep | Number of Participants with analyzable data for this outcome measure | Posted | Mean | Standard Deviation | minutes | 12 weeks |
|
|
|
| Secondary | Short-Form Health Survey - Version 2 (SF-36) | The Short-Form Health Survey - version 2 (SF-36) is a self-report inventory measuring different domains of health-related quality of life: Physical Functioning, Physical Role Functioning, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Functioning, and Mental Health. Scores range from 0 to 100, with higher scores indicating better perceived health and functioning. | Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) measures satisfaction and enjoyment in various domains of functioning: physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and ranges from 0 to 100. Higher scores indicate greater enjoyment and satisfaction. | Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Social Adjustment Scale - Self-Report (SAS-SR) | The Social Adjustment Scale - Self-Report (SAS-SR) is a 54-item self-report measure of instrumental and expressive role performance. Each item is rated on a 5-point scale, and a mean item score (ranging from 1-5) is obtained, with higher scores indicating greater impairment. | Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution. | Posted | Mean | Standard Deviation | mean score on a scale | 12 Weeks |
|
|
|
| Secondary | Work and Social Adjustment Scale (WSAS) | The Work and Social Adjustment Scale (WSAS) is 5-item self-report measure designed to identify functional impairment that is attributed to an identified problem or condition. and has been used in studies of depression and anxiety. Scores range between 0-40, with higher scores indicating worse functioning. | Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Work Productivity and Activity Impairment Questionnaire (WPAI) | The Work Productivity and Activity Impairment Questionnaire (WPAI) was used to report impairment while working or performing usual daily activities as a result of health problems. The activity impairment item (#6 of WPAI) is rated on a scale of 0-10, with higher scores indicating greater impairment. Scores are multiplied by 10 to obtain percent impairment. | Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution. | Posted | Mean | Standard Deviation | percentage of time activity was impaired | 12 Weeks |
|
|
|
| Secondary | Patient Perception of Benefits of Care (PPBC) | The Patient Perception of Benefits of Care (PPBC) assesses how much patients believe their quality of life will improve in response to medical care or treatment. Scores range between 10-50, with lower scores indicating greater belief that treatment will improve quality of life. | Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Hamilton Rating Scale for Depression 17-item | The Hamilton Rating Scale for Depression is a clinician-administered rating scale that assesses severity of depressive symptoms and is one of the most widely used and validated symptom severity measures for depression. Each of the 17 items is rated by the clinician on either a 3- or a 5 point scale. Total scores range from 0-52, with higher scores indicating greater depressive symptoms. | Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| 0 |
| 14 |
| 13 |
| 14 |
| EG001 | Escitalopram + Placebo | Placebo augmentation | 0 | 15 | 15 | 15 |
| vivid dreams | Nervous system disorders | Non-systematic Assessment |
|
| pain and discomfort in genital area | Reproductive system and breast disorders | Non-systematic Assessment |
|
| sinus headache | Nervous system disorders | Non-systematic Assessment |
|
| palpitations | Cardiac disorders | Non-systematic Assessment |
|
| tiredness | General disorders | Non-systematic Assessment |
|
| insomnia | Nervous system disorders | Non-systematic Assessment |
|
| heartburn/indigestion/dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| muscle and joint aches and pains | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| increased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| weight gain | Gastrointestinal disorders | Non-systematic Assessment |
|
| metallic taste | Nervous system disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| altered taste | Nervous system disorders | Non-systematic Assessment |
|
| lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| tingling | Nervous system disorders | Non-systematic Assessment |
|
| head fullness | Nervous system disorders | Non-systematic Assessment |
|
| fidgetiness/restlesness | Nervous system disorders | Non-systematic Assessment |
|
| increased urination | Renal and urinary disorders | Non-systematic Assessment |
|
| stomach cramps | Gastrointestinal disorders | Non-systematic Assessment |
|
| swollen lymph node | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| increased yawning | General disorders | Non-systematic Assessment |
|
| erectile dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
|
| sinus infection/allergy | General disorders | Non-systematic Assessment |
|
| increased perspiration | General disorders | Non-systematic Assessment |
|
| dizziness | General disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| decreased libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| pulled back muscle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hot flashes | Reproductive system and breast disorders | Non-systematic Assessment |
|
| blurred vision | Eye disorders | Non-systematic Assessment |
|
| heart pounding | Cardiac disorders | Non-systematic Assessment |
|
| increased anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| chills | General disorders | Non-systematic Assessment |
|
| fever | General disorders | Non-systematic Assessment |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Physical Role Functioning |
|
| Emotional Role Functioning |
|
| Mental Health |
|
| Vitality |
|
| Bodily Pain |
|
| General Health |
|