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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Escitalopram placebo

Gaboxadol placebo

Escitalopram 20 mg

Gaboxadol 5 mg

Gaboxadol 10 mg

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Escitalopram placebo and gaboxadol placebo

Escitalopram 20 mg and gaboxadol placebo

Escitalopram 20 mg and gaboxadol 5 mg

Escitalopram 20 mg and gaboxadol 10 mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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).

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).

Full Information

NCT ID

NCT00807248

First Posted

December 10, 2008

Last Updated

December 13, 2012

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT00807248

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

490 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Escitalopram placebo and gaboxadol placebo

Arm Type

Placebo Comparator

Arm Title

Escitalopram 20 mg and gaboxadol placebo

Arm Type

Active Comparator

Arm Title

Escitalopram 20 mg and gaboxadol 5 mg

Arm Type

Experimental

Arm Title

Escitalopram 20 mg and gaboxadol 10 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Escitalopram placebo

Intervention Description

Once daily before bedtime for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Gaboxadol placebo

Intervention Description

Once daily before bedtime for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Escitalopram 20 mg

Other Intervention Name(s)

Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa

Intervention Description

Once daily before bedtime for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Gaboxadol 5 mg

Intervention Description

Once daily before bedtime for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Gaboxadol 10 mg

Intervention Description

Once daily before bedtime for 8 weeks

Primary Outcome Measure Information:

Title

Montgomery and Åsberg Depression Rating Scale (MADRS)

Description

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.

Time Frame

Baseline to 8 weeks

Secondary Outcome Measure Information:

Title

MADRS

Description

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.

Time Frame

From baseline to Week 8

Title

Hospital Anxiety and Depression Scale (HADS)

Description

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.

Time Frame