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

Sponsor:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00807248

Purpose

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

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Escitalopram placebo Drug: Gaboxadol placebo Drug: Escitalopram 20 mg Drug: Gaboxadol 5 mg Drug: Gaboxadol 10 mg	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Gaboxadol Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:

Montgomery and Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
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 Outcome Measures:

MADRS [ Time Frame: From baseline to Week 8 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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).

Enrollment:	490
Study Start Date:	November 2008
Study Completion Date:	February 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa Drug: Gaboxadol 10 mg Once daily before bedtime for 8 weeks

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807248

Locations

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

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

No publications provided

Responsible Party:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00807248 History of Changes
Other Study ID Numbers:	12213A, 2008-000506-36
Study First Received:	December 10, 2008
Results First Received:	June 15, 2011
Last Updated:	July 15, 2011
Health Authority:	Austria: Federal Office for Safety in Health Care; Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012