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

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ClinicalTrials.gov Identifier: NCT00807248
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : August 11, 2011
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 11, 2008
Results First Submitted Date  ICMJE June 15, 2011
Results First Posted Date  ICMJE August 11, 2011
Last Update Posted Date December 17, 2012
Study Start Date  ICMJE November 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Montgomery and Åsberg Depression Rating Scale (MADRS) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
Montgomery and Åsberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00807248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
  • MADRS [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Escitalopram placebo
    Once daily before bedtime for 8 weeks
  • Drug: Gaboxadol placebo
    Once daily before bedtime for 8 weeks
  • Drug: Escitalopram 20 mg
    Once daily before bedtime for 8 weeks
    Other Name: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa
  • Drug: Gaboxadol 5 mg
    Once daily before bedtime for 8 weeks
  • Drug: Gaboxadol 10 mg
    Once daily before bedtime for 8 weeks
Study Arms  ICMJE
  • Placebo Comparator: Escitalopram placebo and gaboxadol placebo
    Interventions:
    • Drug: Escitalopram placebo
    • Drug: Gaboxadol placebo
  • Active Comparator: Escitalopram 20 mg and gaboxadol placebo
    Interventions:
    • Drug: Gaboxadol placebo
    • Drug: Escitalopram 20 mg
  • Experimental: Escitalopram 20 mg and gaboxadol 5 mg
    Interventions:
    • Drug: Escitalopram 20 mg
    • Drug: Gaboxadol 5 mg
  • Experimental: Escitalopram 20 mg and gaboxadol 10 mg
    Interventions:
    • Drug: Escitalopram 20 mg
    • Drug: Gaboxadol 10 mg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2010)
490
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2008)
500
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807248
Other Study ID Numbers  ICMJE 12213A
2008-000506-36 ( Registry Identifier: EudraCT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP