Major Depressive DisorderPhase 2NCT00807248

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

A Phase 2 study testing Escitalopram 20 mg, Gaboxadol 5 mg and Gaboxadol 10 mg in people with Major Depressive Disorder, run by H. Lundbeck A/S at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Escitalopram 20 mg, Gaboxadol 5 mg and Gaboxadol 10 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 490 participants
Where: 22 sitesin 2 countries
Study dates: Nov 2008to Feb 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 9Show fewer

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.

Trial locations and contacts

22 sites in 2 countries.

Country

City, postcode or hospital

22 sites in 2 countries

Russia21 sites

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

Other trials in Russia

Austria1 site

AT001
Vienna, 1090

Other trials in Austria

About this 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

Read the 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

Conditions: Major Depressive Disorder
Being tested: Escitalopram placebo, Gaboxadol placebo, Escitalopram 20 mg, Gaboxadol 5 mg, Gaboxadol 10 mg
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Escitalopram placeboDrug
Once daily before bedtime for 8 weeks
Gaboxadol placeboDrug
Once daily before bedtime for 8 weeks
Escitalopram 20 mgDrug
Also called Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa
Once daily before bedtime for 8 weeks
Gaboxadol 5 mgDrug
Once daily before bedtime for 8 weeks
Gaboxadol 10 mgDrug
Once daily before bedtime for 8 weeks

Study groups in NCT00807248
Study group	Role	What they receive
Escitalopram placebo and gaboxadol placebo	Placebo comparator	Not described Receives: Drug: Escitalopram placebo; Drug: Gaboxadol placebo
Escitalopram 20 mg and gaboxadol placebo	Active comparator	Not described Receives: Drug: Gaboxadol placebo; Drug: Escitalopram 20 mg
Escitalopram 20 mg and gaboxadol 5 mg	Experimental	Not described Receives: Drug: Escitalopram 20 mg; Drug: Gaboxadol 5 mg
Escitalopram 20 mg and gaboxadol 10 mg	Experimental	Not described Receives: Drug: Escitalopram 20 mg; Drug: Gaboxadol 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 8 weeks

Secondary outcomes (8)

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.
Measured: From baseline to Week 8
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.
Measured: Mean change from baseline to Week 8
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.
Measured: Mean change from baseline to Week 8
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.
Measured: Mean change from baseline to Week 8
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.
Measured: Mean change from baseline to Week 8
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.
Measured: Mean change from baseline to Week 8
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).
Measured: Mean change from baseline to Week 8
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).
Measured: at Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Feb 2010

First posted11 Dec 2008 (estimated)
Study startNov 2008
Primary completionDec 2009
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 490 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00807248
Sponsor's protocol ID: 12213A
Other IDs: 2008-000506-36, 2008
Status last verified: Dec 2012
First submitted: 10 Dec 2008
Last updated: 17 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kasper S, Ebert B, Larsen K, Tonnoir B. Combining escitalopram with gaboxadol provides no additional benefit in the treatment of patients with severe major depressive disorder. Int J Neuropsychopharmacol. 2012 Jul;15(6):715-25. doi: 10.1017/S146114571100112X. Epub 2011 Oct 19.
PubMed 22008735

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00807248
Acronym / sponsor ID: 12213A
Conditions: Major Depressive Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 490 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Dec 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 11 Dec 2008 (estimated)
Results: Posted 11 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Escitalopram placebo and gaboxadol placebo	Placebo comparator	Drug: Escitalopram placebo, Drug: Gaboxadol placebo
Escitalopram 20 mg and gaboxadol placebo	Active comparator	Drug: Gaboxadol placebo, Drug: Escitalopram 20 mg
Escitalopram 20 mg and gaboxadol 5 mg	Experimental	Drug: Escitalopram 20 mg, Drug: Gaboxadol 5 mg
Escitalopram 20 mg and gaboxadol 10 mg	Experimental	Drug: Escitalopram 20 mg, Drug: Gaboxadol 10 mg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

With reported duration of the current major depressive episode of at least 3 months
With MADRS total score of at least 30

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Escitalopram placeboOnce daily before bedtime for 8 weeks	Drug	Escitalopram placebo and gaboxadol placebo
Gaboxadol placeboOnce daily before bedtime for 8 weeks	Drug	Escitalopram 20 mg and gaboxadol placebo, Escitalopram placebo and gaboxadol placebo
Escitalopram 20 mgAlso: Escitalopram = Cipralex/Lexapro/Seroplex/SipralexaOnce daily before bedtime for 8 weeks	Drug	Escitalopram 20 mg and gaboxadol 10 mg, Escitalopram 20 mg and gaboxadol 5 mg, Escitalopram 20 mg and gaboxadol placebo
Gaboxadol 5 mgOnce daily before bedtime for 8 weeks	Drug	Escitalopram 20 mg and gaboxadol 5 mg
Gaboxadol 10 mgOnce daily before bedtime for 8 weeks	Drug	Escitalopram 20 mg and gaboxadol 10 mg

Primary outcome

Montgomery and Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline to 8 weeks
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.

8 secondary outcomes

MADRS
Time frame: From baseline to Week 8
Hospital Anxiety and Depression Scale (HADS)
Time frame: Mean change from baseline to Week 8
Insomnia Severity Index (ISI)
Time frame: Mean change from baseline to Week 8
Sheehan Disability Scale (SDS): Family Subscale
Time frame: Mean change from baseline to Week 8
SDS: Work Subscale
Time frame: Mean change from baseline to Week 8
SDS: Social Subscale
Time frame: Mean change from baseline to Week 8
Clinical Global Impression - Severity of Illness (CGI-S)
Time frame: Mean change from baseline to Week 8
Clinical Global Impression - Global Improvement (CGI-I)
Time frame: at Week 8

Results and safety

Results posted to the registry on 11 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Orally, Once Daily)	71	50
Escitalopram 20 mg and Placebo (Orally, Once Daily)	140	128
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)	139	121
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)	140	126

Primary outcome: Montgomery and Åsberg Depression Rating Scale (MADRS)

Time frame: Baseline to 8 weeks. Mean (Standard Error). Unit: Scores on a scale

Measure	Placebo (Orally, Once Daily) n = 71	Escitalopram 20 mg and Placebo (Orally, Once Daily) n = 139	Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) n = 139	Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) n = 140
Value	-13.4 (1.1)	-19.0 (0.9)	-18.5 (0.9)	-19.4 (0.9)

Escitalopram 20 mg and Placebo (Orally, Once Daily) vs Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily): Mean Difference (Final Values): -0.45 (95% CI -2.34 to 1.44), p = 0.6405, ANCOVA
Escitalopram 20 mg and Placebo (Orally, Once Daily) vs Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily): Mean Difference (Final Values): 0.47 (95% CI -1.41 to 2.35), p = 0.6227, ANCOVA

Population analysed: Mean change from baseline to Week 8: Full-analysis Set (FAS), Last Observation Carried Forward (LOCF), Analysis of Covariance (ANCOVA)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Orally, Once Daily)	1 of 71 (1.4%)	12 of 71 (16.9%)	Not reported
Escitalopram 20 mg and Placebo (Orally, Once Daily)	0 of 140 (0%)	22 of 140 (15.7%)	Not reported
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)	0 of 139 (0%)	31 of 139 (22.3%)	Not reported
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)	0 of 140 (0%)	19 of 140 (13.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22008735Kasper S, Ebert B, Larsen K, Tonnoir B. Combining escitalopram with gaboxadol provides no additional benefit in the treatment of patients with severe major depressive disorder. Int J Neuropsychopharmacol. 2012 Jul;15(6):715-25. doi: 10.1017/S146114571100112X. Epub 2011 Oct 19.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Email contact via H. Lundbeck A/S study director

LundbeckClinicalTrials@lundbeck.com

22 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Escitalopram 20 mg, Gaboxadol 5 mg and Gaboxadol 10 mg in people with Major Depressive Disorder, run by H. Lundbeck A/S at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Russia, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery and Åsberg Depression Rating Scale (MADRS) (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00807248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.