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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2009

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

Intervention(s) in this Clinical Trial

• Drug: Escitalopram and Gaboxadol
  • Escitalopram 20mg + Gaboxadol 10mg once daily before bedtime for 8 weeks
• Drug: Escitalopram and Gaboxadol
  • Escitalopram 20mg + Gaboxadol 5mg once daily before bedtime for 8 weeks
• Drug: Escitalopram and Placebo
  • Escitalopram 20mg + Gaboxadol Placebo once daily before bedtime for 8 weeks
• Drug: Placebo
  • Placebo: Escitalopram Placebo + Gaboxadol Placebo once daily before bedtime for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3
• Placebo Comparator: 4

Primary Measures

• Montgomery and Asberg Depression Rating Scale (MADRS)
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• 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)
  • Time Frame: 8 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: H. Lundbeck A/S

Overall Clinical Trial Officials and Contacts

Email contact via H. Lundbeck A/S Study Director LundbeckClinicalTrials@lundbeck.com  

Overall Contact: Email contact via H. Lundbeck A/S  LundbeckClinicalTrials@lundbeck.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00807248

Study ID Number: 12213A

ClinicalTrials.gov Identifier: NCT00807248

Health Authority: Austria: Federal Office for Safety in Health Care