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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807248
• Other study ID #: 12213A
• Secondary ID: 2008-000506-36
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2008
• Last updated: December 13, 2012
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: December 2012
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram placebo
Once daily before bedtime for 8 weeks
• Gaboxadol placebo
Once daily before bedtime for 8 weeks
• Escitalopram 20 mg
Once daily before bedtime for 8 weeks
• Gaboxadol 5 mg
Once daily before bedtime for 8 weeks
• Gaboxadol 10 mg
Once daily before bedtime for 8 weeks

Locations

Country	Name	City	State
Austria	AT001	Vienna
Russian Federation	RU019	Barnaul
Russian Federation	RU018	Ekaterinburg
Russian Federation	RU029	Izhevsk
Russian Federation	RU020	Kemerovo
Russian Federation	RU010	Krasnodar
Russian Federation	RU012	Krasnodar
Russian Federation	RU022	Kursk
Russian Federation	RU001	Moscow
Russian Federation	RU002	Moscow
Russian Federation	RU003	Moscow
Russian Federation	RU007	Moscow
Russian Federation	RU015	Moscow
Russian Federation	RU026	Moscow
Russian Federation	RU028	Moscow
Russian Federation	RU027	Saransk
Russian Federation	RU013	Saratov
Russian Federation	RU024	Saratov
Russian Federation	RU021	Tomsk
Russian Federation	RU016	Tver
Russian Federation	RU014	Volgograd
Russian Federation	RU011	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Austria,  Russian Federation, 

References & Publications (1)

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/S1461145711001 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 8 weeks	No
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.	From baseline to Week 8	No
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	No
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	No
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	No
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	No
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	No
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	No
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	No