Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT00807248
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 490
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Escitalopram placebo and gaboxadol placebo Gaboxadol placebo - Escitalopram 20 mg and gaboxadol placebo Gaboxadol placebo - Escitalopram 20 mg and gaboxadol 5 mg Escitalopram 20 mg - Escitalopram 20 mg and gaboxadol 5 mg Gaboxadol 5 mg - Escitalopram placebo and gaboxadol placebo Escitalopram placebo - Escitalopram 20 mg and gaboxadol placebo Escitalopram 20 mg - Escitalopram 20 mg and gaboxadol 10 mg Escitalopram 20 mg - Escitalopram 20 mg and gaboxadol 10 mg Gaboxadol 10 mg -
- Primary Outcome Measures
Name Time Method Montgomery and Åsberg Depression Rating Scale (MADRS) Baseline to 8 weeks 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.
- Secondary Outcome Measures
Name Time Method MADRS From baseline to Week 8 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.
Hospital Anxiety and Depression Scale (HADS) Mean change from baseline to Week 8 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.
Insomnia Severity Index (ISI) Mean change from baseline to Week 8 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.
Sheehan Disability Scale (SDS): Family Subscale Mean change from baseline to Week 8 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.
SDS: Work Subscale Mean change from baseline to Week 8 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.
SDS: Social Subscale Mean change from baseline to Week 8 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.
Clinical Global Impression - Severity of Illness (CGI-S) Mean change from baseline to Week 8 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).
Clinical Global Impression - Global Improvement (CGI-I) at Week 8 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).
Trial Locations
- Locations (22)
RU011
🇷🇺Yaroslavl, Russian Federation
RU014
🇷🇺Volgograd, Russian Federation
RU015
🇷🇺Moscow, Russian Federation
AT001
🇦🇹Vienna, Austria
RU018
🇷🇺Ekaterinburg, Russian Federation
RU029
🇷🇺Izhevsk, Russian Federation
RU020
🇷🇺Kemerovo, Russian Federation
RU010
🇷🇺Krasnodar, Russian Federation
RU022
🇷🇺Kursk, Russian Federation
RU026
🇷🇺Moscow, Russian Federation
RU002
🇷🇺Moscow, Russian Federation
RU001
🇷🇺Moscow, Russian Federation
RU028
🇷🇺Moscow, Russian Federation
RU003
🇷🇺Moscow, Russian Federation
RU027
🇷🇺Saransk, Russian Federation
RU013
🇷🇺Saratov, Russian Federation
RU016
🇷🇺Tver, Russian Federation
RU007
🇷🇺Moscow, Russian Federation
RU024
🇷🇺Saratov, Russian Federation
RU012
🇷🇺Krasnodar, Russian Federation
RU021
🇷🇺Tomsk, Russian Federation
RU019
🇷🇺Barnaul, Russian Federation