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Completed

NCT Number: NCT00807248

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

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AT001, Vienna, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram placebo

Drug

Once daily before bedtime for 8 weeks

Gaboxadol placebo

Drug

Once daily before bedtime for 8 weeks

Escitalopram 20 mg

Drug

Once daily before bedtime for 8 weeks

Other names: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa

Gaboxadol 5 mg

Drug

Once daily before bedtime for 8 weeks

Gaboxadol 10 mg

Drug

Once daily before bedtime for 8 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Dec 11, 2008
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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