Clinical trial NCT00807248: Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery and Åsberg Depression Rating Scale (MADRS)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: MADRS
timeFrame: From baseline to Week 8
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Mean change from baseline to Week 8
measure: Insomnia Severity Index (ISI)
timeFrame: Mean change from baseline to Week 8
measure: Sheehan Disability Scale (SDS): Family Subscale
timeFrame: Mean change from baseline to Week 8
measure: SDS: Work Subscale
timeFrame: Mean change from baseline to Week 8
measure: SDS: Social Subscale
timeFrame: Mean change from baseline to Week 8
measure: Clinical Global Impression - Severity of Illness (CGI-S)
timeFrame: Mean change from baseline to Week 8
measure: Clinical Global Impression - Global Improvement (CGI-I)
timeFrame: at Week 8
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AT001
city: Barnaul
country: Russian Federation
facility: RU019
city: Ekaterinburg
country: Russian Federation
facility: RU018
city: Izhevsk
country: Russian Federation
facility: RU029
city: Kemerovo
country: Russian Federation
facility: RU020
city: Krasnodar
country: Russian Federation
facility: RU012
city: Krasnodar
country: Russian Federation
facility: RU010
city: Kursk
country: Russian Federation
facility: RU022
city: Moscow
country: Russian Federation
facility: RU015
city: Moscow
country: Russian Federation
facility: RU026
city: Moscow
country: Russian Federation
facility: RU001
city: Moscow
country: Russian Federation
facility: RU002
city: Moscow
country: Russian Federation
facility: RU028
city: Moscow
country: Russian Federation
facility: RU003
city: Moscow
country: Russian Federation
facility: RU007
city: Saransk
country: Russian Federation
facility: RU027
city: Saratov
country: Russian Federation
facility: RU024
city: Saratov
country: Russian Federation
facility: RU013
city: Tomsk
country: Russian Federation
facility: RU021
city: Tver
country: Russian Federation
facility: RU016
city: Volgograd
country: Russian Federation
facility: RU014
city: Yaroslavl
country: Russian Federation
facility: RU011
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.