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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Major Depressive Disorder
Interventions:	Drug: Escitalopram placebo Drug: Gaboxadol placebo Drug: Escitalopram 20 mg Drug: Gaboxadol 5 mg Drug: Gaboxadol 10 mg

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The patients were recruited from specialist inpatient and outpatient clinics.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo (Orally, Once Daily)	No text entered.
Escitalopram 20 mg and Placebo (Orally, Once Daily)	No text entered.
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)	No text entered.
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)	No text entered.

Participant Flow: Overall Study

	Placebo (Orally, Once Daily)	Escitalopram 20 mg and Placebo (Orally, Once Daily)	Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)	Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
STARTED	71	140	139	140
COMPLETED	50	128	121	126
NOT COMPLETED	21	12	18	14
Adverse Event	1	2	2	6
Lack of Efficacy	14	4	8	3
Protocol Violation	0	1	1	0
Withdrawal of Consent	5	5	5	5
Lost to Follow-up	1	0	0	0
Other Reason	0	0	2	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo (Orally, Once Daily)	No text entered.
Escitalopram 20 mg and Placebo (Orally, Once Daily)	No text entered.
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)	No text entered.
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)	No text entered.

Baseline Measures

	Placebo (Orally, Once Daily)	Escitalopram 20 mg and Placebo (Orally, Once Daily)	Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)	Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)	Total
Number of Participants [units: participants]	71	140	139	140	490
Age [units: years] Mean ± Standard Deviation	42.6 ± 11.6	41.6 ± 12.6	42.6 ± 11.8	41.5 ± 10.5	42.0 ± 11.7
Gender [units: participants]
Female	53	96	96	93	338
Male	18	44	43	47	152
Montgomery and Åsberg Depression Rating Scale (MADRS) ^[1] [units: Scores on a scale] Mean ± Standard Deviation	34.7 ± 4.2	35.4 ± 4.3	35.3 ± 3.4	34.7 ± 3.8	35.1 ± 3.9
Hospital Anxiety and Depression Scale (HADS) ^[2] [units: Scores on a scale] Mean ± Standard Deviation	27.5 ± 5.9	28.2 ± 5.3	28.1 ± 5.5	27.4 ± 5.5	27.8 ± 5.5
Insomnia Severity Index (ISI) ^[3] [units: Scores on a scale] Mean ± Standard Deviation	18.4 ± 5.0	18.6 ± 4.7	18.2 ± 4.4	18.1 ± 4.8	18.3 ± 4.7
Sheehan Disability Scale (SDS): Family Subscale ^[4] [units: Scores on a scale] Mean ± Standard Deviation	7.0 ± 1.4	7.1 ± 1.6	7.2 ± 1.3	6.9 ± 1.4	7.1 ± 1.4
SDS: Work Subscale ^[4] [units: Scores on a scale] Mean ± Standard Deviation	7.3 ± 1.2	7.4 ± 1.3	7.3 ± 1.5	7.0 ± 1.4	7.2 ± 1.4
SDS: Social Subscale ^[4] [units: Scores on a scale] Mean ± Standard Deviation	7.0 ± 1.4	7.1 ± 1.4	7.1 ± 1.5	6.9 ± 1.6	7.0 ± 1.5
Clinical Global Impression - Severity of Illness (CGI-S) ^[5] [units: Scores on a scale] Mean ± Standard Deviation	4.4 ± 0.9	4.5 ± 0.9	4.3 ± 0.9	4.4 ± 0.9	4.4 ± 0.9

[1]	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]	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]	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]	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]	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).

Outcome Measures

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1. Primary:

Montgomery and Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline to 8 weeks ]

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2. Secondary:

MADRS [ Time Frame: From baseline to Week 8 ]

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3. Secondary:

Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Mean change from baseline to Week 8 ]

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4. Secondary:

Insomnia Severity Index (ISI) [ Time Frame: Mean change from baseline to Week 8 ]

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5. Secondary:

Sheehan Disability Scale (SDS): Family Subscale [ Time Frame: Mean change from baseline to Week 8 ]

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6. Secondary:

SDS: Work Subscale [ Time Frame: Mean change from baseline to Week 8 ]

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7. Secondary:

SDS: Social Subscale [ Time Frame: Mean change from baseline to Week 8 ]

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8. Secondary:

Clinical Global Impression - Severity of Illness (CGI-S) [ Time Frame: Mean change from baseline to Week 8 ]

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9. Secondary:

Clinical Global Impression - Global Improvement (CGI-I) [ Time Frame: at Week 8 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The main publication has to be published before any sub-publications.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: H. Lundbeck A/S
Organization: H. Lundbeck A/S
phone: +45 3630 1311
e-mail: LundbeckClinicalTrials@lundbeck.com

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