Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
Information source: H. Lundbeck A/S
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Escitalopram and Gaboxadol (Drug); Escitalopram and Gaboxadol (Drug); Escitalopram and Placebo (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: H. Lundbeck A/S Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com
Overall contact:
Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com
Summary
To compare the efficacy of escitalopram fixed dose 20mg/day in combination with fixed doses
of gaboxadol (5 & 10mg/day) versus escitalopram fixed dose 20mg/day after 8 weeks of
treatment in patients with Major Depressive Disorder
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Primary outcome: Montgomery and Asberg Depression Rating Scale (MADRS)
Secondary outcome: Clinical Global Impression: - Global Improvement (CGI-I) and - Severity of Illness (CGI-S); Sheehan Disability Scale (SDS); Hospital Anxiety and Depression (HAD); Insomnia Severity Index (ISI)
Detailed description:
Subjects participating in this study will be respectively randomised (2: 2:2: 1) to receive
either:
- escitalopram 20mg/day in combination with gaboxadol 5mg/day or
- escitalopram 20mg/day in combination with gaboxadol 10mg/day or
- escitalopram 20mg/day or
- placebo
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com
AT001, Vienna 1090, Austria; Recruiting
RU007, Moscow 144009, Russian Federation; Recruiting
RU001, Moscow 119992, Russian Federation; Recruiting
RU002, Moscow 119992, Russian Federation; Recruiting
RU003, Moscow 127083, Russian Federation; Recruiting
RU010, Krasnodar 350087, Russian Federation; Recruiting
RU011, Yaroslavl 150003, Russian Federation; Recruiting
RU012, Krasnodar 350007, Russian Federation; Recruiting
RU013, Saratov 410060, Russian Federation; Recruiting
RU014, Volgograd, Russian Federation; Recruiting
RU016, Tver 170005, Russian Federation; Recruiting
RU018, Ekaterinburg 620905, Russian Federation; Recruiting
RU019, Barnaul 656022, Russian Federation; Recruiting
RU020, Kemerovo 650036, Russian Federation; Recruiting
RU021, Tomsk 634014, Russian Federation; Recruiting
RU022, Kursk 30500, Russian Federation; Recruiting
RU024, Saratov 410038, Russian Federation; Recruiting
RU026, Moscow 115522, Russian Federation; Recruiting
RU027, Saransk 430030, Russian Federation; Recruiting
RU029, Izhevsk 426054, Russian Federation; Recruiting
RU015, Moscow 107076, Russian Federation; Recruiting
RU028, Moscow 119992, Russian Federation; Recruiting
Additional Information
Starting date: November 2008
Ending date: February 2010
Last updated: October 7, 2009
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