NCT00807248|CompletedPhase 2Results

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

H. Lundbeck A/S ClinicalTrials.gov

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2 other identifiers

12213A2008-000506-36

Study Type

interventional

Target

490

Locations

2 countries

Sites

Timeline

RegisteredDec 2008

StartedNov 2008

CompletionFeb 2010

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

490

participants targeted

Target at P75+ for phase_2 major-depressive-disorder

Timeline

Completed

Started Nov 2008

Geographic Reach

2 countries

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

November 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

August 11, 2011

Completed

Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

December 10, 2008

Results QC Date

June 15, 2011

Last Update Submit

December 13, 2012

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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 Outcomes (8)

MADRS
From baseline to Week 8
Hospital Anxiety and Depression Scale (HADS)
Mean change from baseline to Week 8
Insomnia Severity Index (ISI)
Mean change from baseline to Week 8
Sheehan Disability Scale (SDS): Family Subscale
Mean change from baseline to Week 8
SDS: Work Subscale
Mean change from baseline to Week 8
+3 more secondary outcomes

Study Arms (4)

Escitalopram placebo and gaboxadol placebo

PLACEBO COMPARATOR

Drug: Escitalopram placeboDrug: Gaboxadol placebo

Escitalopram 20 mg and gaboxadol placebo

ACTIVE COMPARATOR

Drug: Gaboxadol placeboDrug: Escitalopram 20 mg

Escitalopram 20 mg and gaboxadol 5 mg

EXPERIMENTAL

Drug: Escitalopram 20 mgDrug: Gaboxadol 5 mg

Escitalopram 20 mg and gaboxadol 10 mg

EXPERIMENTAL

Drug: Escitalopram 20 mgDrug: Gaboxadol 10 mg