Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder

Study Overview
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Brief Summary
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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

Detailed Description
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Subjects participating in this study will be respectively randomised (1:2:2:2) to receive either: placebo or escitalopram 20 mg/day or escitalopram 20 mg/day in combination with gaboxadol 5 mg/day or escitalopram 20 mg/day in combination with gaboxadol 10 mg/day

Official Title
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Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study of Escitalopram in Combination With Two Fixed Doses of Gaboxadol Compared to Escitalopram in Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Escitalopram placebo
* Drug: Gaboxadol placebo
* Drug: Escitalopram 20 mg
* Drug: Gaboxadol 5 mg
* Drug: Gaboxadol 10 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Diagnosis of MDD according to DSM-IV-TR criteria: With reported duration of the current major depressive episode of at least 3 months With MADRS total score of at least 30 Exclusion Criteria: The patient has 1 or more of the following: Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR Presence or history of a clinically significant neurological disorder (including epilepsy) Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc) Any Axis II disorder that might compromise the study Previous use of hallucinogenic drug 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Escitalopram placebo and gaboxadol placebo<br> | Drug: Escitalopram placebo<br>* Once daily before bedtime for 8 weeks<br>Drug: Gaboxadol placebo<br>* Once daily before bedtime for 8 weeks<br>|
| Active Comparator: Escitalopram 20 mg and gaboxadol placebo<br> | Drug: Gaboxadol placebo<br>* Once daily before bedtime for 8 weeks<br>Drug: Escitalopram 20 mg<br>* Once daily before bedtime for 8 weeks<br>* Other names: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa;|
| Experimental: Escitalopram 20 mg and gaboxadol 5 mg<br> | Drug: Escitalopram 20 mg<br>* Once daily before bedtime for 8 weeks<br>* Other names: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa;Drug: Gaboxadol 5 mg<br>* Once daily before bedtime for 8 weeks<br>|
| Experimental: Escitalopram 20 mg and gaboxadol 10 mg<br> | Drug: Escitalopram 20 mg<br>* Once daily before bedtime for 8 weeks<br>* Other names: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa;Drug: Gaboxadol 10 mg<br>* Once daily before bedtime for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |