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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000506-36 | Registry Identifier | EudraCT |
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To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of treatment in patients with Major Depressive Disorder
Subjects participating in this study will be respectively randomised (1:2:2:2) to receive either:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram placebo and gaboxadol placebo | Placebo Comparator |
| |
| Escitalopram 20 mg and gaboxadol placebo | Active Comparator |
| |
| Escitalopram 20 mg and gaboxadol 5 mg | Experimental |
| |
| Escitalopram 20 mg and gaboxadol 10 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram placebo | Drug | Once daily before bedtime for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery and Åsberg Depression Rating Scale (MADRS) | The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MADRS | The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. | From baseline to Week 8 |
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Inclusion Criteria:
Clinical Diagnosis of MDD according to DSM-IV-TR criteria:
Exclusion Criteria:
The patient has 1 or more of the following:
The patient has a significant risk of suicide according to the investigator's opinion, or has a score >=5 on item 10 (suicidal thoughts) of the MADRS, or has made a suicide attempt in the previous 12 months.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AT001 | Vienna | 1090 | Austria | |||
| RU019 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22008735 | Result | Kasper S, Ebert B, Larsen K, Tonnoir B. Combining escitalopram with gaboxadol provides no additional benefit in the treatment of patients with severe major depressive disorder. Int J Neuropsychopharmacol. 2012 Jul;15(6):715-25. doi: 10.1017/S146114571100112X. Epub 2011 Oct 19. |
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The patients were recruited from specialist inpatient and outpatient clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Orally, Once Daily) | |
| FG001 | Escitalopram 20 mg and Placebo (Orally, Once Daily) | |
| FG002 | Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Gaboxadol placebo | Drug | Once daily before bedtime for 8 weeks |
|
| Escitalopram 20 mg | Drug | Once daily before bedtime for 8 weeks |
|
|
| Gaboxadol 5 mg | Drug | Once daily before bedtime for 8 weeks |
|
| Gaboxadol 10 mg | Drug | Once daily before bedtime for 8 weeks |
|
| Hospital Anxiety and Depression Scale (HADS) | The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42. | Mean change from baseline to Week 8 |
| Insomnia Severity Index (ISI) | The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient's perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms. | Mean change from baseline to Week 8 |
| Sheehan Disability Scale (SDS): Family Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean change from baseline to Week 8 |
| SDS: Work Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean change from baseline to Week 8 |
| SDS: Social Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean change from baseline to Week 8 |
| Clinical Global Impression - Severity of Illness (CGI-S) | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | Mean change from baseline to Week 8 |
| Clinical Global Impression - Global Improvement (CGI-I) | The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | at Week 8 |
| Barnaul |
| 656022 |
| Russia |
| RU029 | Izhevsk | 426054 | Russia |
| RU020 | Kemerovo | 650036 | Russia |
| RU012 | Krasnodar | 350007 | Russia |
| RU010 | Krasnodar | 350087 | Russia |
| RU022 | Kursk | 30500 | Russia |
| RU015 | Moscow | 107076 | Russia |
| RU026 | Moscow | 115522 | Russia |
| RU001 | Moscow | 119992 | Russia |
| RU002 | Moscow | 119992 | Russia |
| RU028 | Moscow | 119992 | Russia |
| RU003 | Moscow | 127083 | Russia |
| RU007 | Moscow | 144009 | Russia |
| RU027 | Saransk | 430030 | Russia |
| RU024 | Saratov | 410038 | Russia |
| RU013 | Saratov | 410060 | Russia |
| RU021 | Tomsk | 634014 | Russia |
| RU016 | Tver' | 170005 | Russia |
| RU014 | Volgograd | Russia |
| RU011 | Yaroslavl | 150003 | Russia |
| RU018 | Yekaterinburg | 620905 | Russia |
| FG003 | Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Orally, Once Daily) | |
| BG001 | Escitalopram 20 mg and Placebo (Orally, Once Daily) | |
| BG002 | Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | |
| BG003 | Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Montgomery and Åsberg Depression Rating Scale (MADRS) | The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Hospital Anxiety and Depression Scale (HADS) | The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Insomnia Severity Index (ISI) | The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient's perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Sheehan Disability Scale (SDS): Family Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| SDS: Work Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| SDS: Social Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Clinical Global Impression - Severity of Illness (CGI-S) | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | Mean | Standard Deviation | Scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Montgomery and Åsberg Depression Rating Scale (MADRS) | The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. | Mean change from baseline to Week 8: Full-analysis Set (FAS), Last Observation Carried Forward (LOCF), Analysis of Covariance (ANCOVA) | Posted | Mean | Standard Error | Scores on a scale | Baseline to 8 weeks |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MADRS | The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. | Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA) | Posted | Least Squares Mean | Standard Error | Scores on a scale | From baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hospital Anxiety and Depression Scale (HADS) | The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42. | Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA) | Posted | Mean | Standard Error | Scores on a scale | Mean change from baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Insomnia Severity Index (ISI) | The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient's perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms. | Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA) | Posted | Mean | Standard Error | Scores on a scale | Mean change from baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sheehan Disability Scale (SDS): Family Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA) | Posted | Mean | Standard Error | Scores on a scale | Mean change from baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SDS: Work Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA) | Posted | Mean | Standard Error | Scores on a scale | Mean change from baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SDS: Social Subscale | The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. | Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA) | Posted | Mean | Standard Error | Scores on a scale | Mean change from baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Severity of Illness (CGI-S) | The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA) | Posted | Mean | Standard Error | Scores on a scale | Mean change from baseline to Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Global Improvement (CGI-I) | The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | At Week 8 (FAS, LOCF, ANCOVA) | Posted | Mean | Standard Error | Scores on a scale | at Week 8 |
|
|
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 | Placebo (Orally, Once Daily) | 1 | 71 | 12 | 71 | |||
| EG001 | Escitalopram 20 mg and Placebo (Orally, Once Daily) | 0 | 140 | 22 | 140 | |||
| EG002 | Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) | 0 | 139 | 31 | 139 | |||
| EG003 | Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) | 0 | 140 | 19 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
The main publication has to be published before any sub-publications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | +45 3630 1311 | LundbeckClinicalTrials@lundbeck.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| C015542 | gaboxadol |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Mean Difference (Final Values) |
| 0.47 |
| Standard Error of the Mean |
| 0.96 |
| 2-Sided |
| 95 |
| -1.41 |
| 2.35 |
| No |
| Superiority or Other |
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| Participants |
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