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 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

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Escitalopram and Gaboxadol Drug: Escitalopram and Placebo Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
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 Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: Experimental	Drug: Escitalopram and Gaboxadol Escitalopram 20mg + Gaboxadol 10mg once daily before bedtime for 8 weeks
2: Experimental	Drug: Escitalopram and Gaboxadol Escitalopram 20mg + Gaboxadol 5mg once daily before bedtime for 8 weeks
3: Active Comparator	Drug: Escitalopram and Placebo Escitalopram 20mg + Gaboxadol Placebo once daily before bedtime for 8 weeks
4: Placebo Comparator	Drug: Placebo Placebo: Escitalopram Placebo + Gaboxadol Placebo once daily before bedtime for 8 weeks

Detailed Description:

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

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

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 ( H. Lundbeck A/S )
Study ID Numbers:	12213A, 2008-000506-36
Study First Received:	December 10, 2008
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00807248 History of Changes
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:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Pathologic Processes
Sensory System Agents
Mental Disorders
Therapeutic Uses

Analgesics
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Disease
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents

ClinicalTrials.gov processed this record on February 08, 2010