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

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 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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Escitalopram placebo; Drug: Gaboxadol placebo; Drug: Escitalopram 20 mg; Drug: Gaboxadol 5 mg; Drug: Gaboxadol 10 mg

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: Interventional
• Enrollment (Actual): 490
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • AT001
• Russian Federation
  • Barnaul, Russian Federation, 656022
    • RU019
  • Ekaterinburg, Russian Federation, 620905
    • RU018
  • Izhevsk, Russian Federation, 426054
    • RU029
  • Kemerovo, Russian Federation, 650036
    • RU020
  • Krasnodar, Russian Federation, 350007
    • RU012
  • Krasnodar, Russian Federation, 350087
    • RU010
  • Kursk, Russian Federation, 30500
    • RU022
  • Moscow, Russian Federation, 107076
    • RU015
  • Moscow, Russian Federation, 115522
    • RU026
  • Moscow, Russian Federation, 119992
    • RU001
  • Moscow, Russian Federation, 119992
    • RU002
  • Moscow, Russian Federation, 119992
    • RU028
  • Moscow, Russian Federation, 127083
    • RU003
  • Moscow, Russian Federation, 144009
    • RU007
  • Saransk, Russian Federation, 430030
    • RU027
  • Saratov, Russian Federation, 410038
    • RU024
  • Saratov, Russian Federation, 410060
    • RU013
  • Tomsk, Russian Federation, 634014
    • RU021
  • Tver, Russian Federation, 170005
    • RU016
  • Volgograd, Russian Federation
    • RU014
  • Yaroslavl, Russian Federation, 150003
    • RU011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Escitalopram placebo and gaboxadol placebo	Drug: Escitalopram placebo; Once daily before bedtime for 8 weeks; Drug: Gaboxadol placebo; Once daily before bedtime for 8 weeks
ACTIVE_COMPARATOR: Escitalopram 20 mg and gaboxadol placebo	Drug: Gaboxadol placebo; Once daily before bedtime for 8 weeks; Drug: Escitalopram 20 mg; Once daily before bedtime for 8 weeks; Other Names: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa
EXPERIMENTAL: Escitalopram 20 mg and gaboxadol 5 mg	Drug: Escitalopram 20 mg; Once daily before bedtime for 8 weeks; Other Names: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa; Drug: Gaboxadol 5 mg; Once daily before bedtime for 8 weeks
EXPERIMENTAL: Escitalopram 20 mg and gaboxadol 10 mg	Drug: Escitalopram 20 mg; Once daily before bedtime for 8 weeks; Other Names: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa; Drug: Gaboxadol 10 mg; Once daily before bedtime for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery and Åsberg Depression Rating Scale (MADRS)	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.	Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS	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.	From baseline to Week 8
Hospital Anxiety and Depression Scale (HADS)	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.	Mean change from baseline to Week 8
Insomnia Severity Index (ISI)	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.	Mean change from baseline to Week 8
Sheehan Disability Scale (SDS): Family Subscale	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.	Mean change from baseline to Week 8
SDS: Work Subscale	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.	Mean change from baseline to Week 8
SDS: Social Subscale	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.	Mean change from baseline to Week 8
Clinical Global Impression - Severity of Illness (CGI-S)	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).	Mean change from baseline to Week 8
Clinical Global Impression - Global Improvement (CGI-I)	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).	at Week 8

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: December 10, 2008
• First Submitted That Met QC Criteria: December 10, 2008
• First Posted (ESTIMATE): December 11, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; GABA Agents; Anticonvulsants; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; GABA Agonists; Citalopram; Dexetimide; Gaboxadol
• Other Study ID Numbers: 12213A; 2008-000506-36 (REGISTRY: EudraCT)