Major Depressive DisorderPhase 2NCT01145755

6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

A Phase 2 study testing AZD2066 and Duloxetine in people with Major Depressive Disorder, run by AstraZeneca at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 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?: AZD2066 and Duloxetine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 131 participants
Where: 13 sitesUnited States
Study dates: May 2010to Nov 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

Provision of signed, written, and dated Informed Consent
Documented primary clinical diagnosis of Major Depressive Disorder

Who cannot join

Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder
Patients whose current episode of depression started less than 4 weeks before enrollment
History of inadequate response of antidepressants during current depressive episode

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Research Site
Atlanta, Georgia
Research Site
Bellevue, Washington
Research Site
Boston, Massachusetts
Research Site
Cedarhurst, New York
Research Site
Friendswood, Texas
Research Site
Garden Grove, California
Research Site
Jacksonville, Florida
Research Site
Memphis, Tennessee
Research Site
Portland, Oregon
Research Site
Rochester, New York
Research Site
Rockville, Maryland
Research Site
San Diego, California
Research Site
Seattle, Washington

Other trials in United States

About this study

Official title: A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020

This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Read the detailed description

A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.

Conditions: Major Depressive Disorder
Being tested: AZD2066, Placebo, Duloxetine
Keywords: Depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

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

AZD2066Drug
18 mg once daily
PlaceboDrug
DuloxetineDrug
60 mg once daily

Study groups in NCT01145755
Study group	Role	What they receive
AZD2066	Experimental	Not described Receives: Drug: AZD2066
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Duloxetine	Active comparator	Duloxetine Receives: Drug: Duloxetine

What is being measured

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

MADRS Total Score Change From Baseline to Week 6
Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.
Measured: 6 weeks

Secondary outcomes (2)

MADRS Response
A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.
Measured: 6 weeks
MADRS Remission
A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6
Measured: 6 weeks

Timeline

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

May 2010Nov 2010

First posted17 Jun 2010 (estimated)
Study startMay 2010
Primary completionNov 2010
Study completionNov 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.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01145755
Sponsor's protocol ID: D0475C00020
Status last verified: Sep 2012
First submitted: 27 May 2010
Last updated: 3 Oct 2012
Results posted: Yes, on ClinicalTrials.gov

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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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020
ClinicalTrials.gov ID: NCT01145755
Acronym / sponsor ID: D0475C00020
Conditions: Major Depressive Disorder
Keywords: Depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 131 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 17 Jun 2010 (estimated)
Results: Posted 27 Sep 2012

Clinical summary

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

This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
AZD2066	Experimental	Drug: AZD2066
Placebo	Placebo comparator	Drug: Placebo
Duloxetine	Active comparator	Drug: DuloxetineDuloxetine

Who may qualify

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

Key inclusion criteria (2 listed)

Provision of signed, written, and dated Informed Consent
Documented primary clinical diagnosis of Major Depressive Disorder

Key exclusion criteria (3 listed)

Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder
Patients whose current episode of depression started less than 4 weeks before enrollment
History of inadequate response of antidepressants during current depressive episode

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
AZD206618 mg once daily	Drug	AZD2066
Placebo	Drug	Placebo
Duloxetine60 mg once daily	Drug	Duloxetine

Primary outcome

MADRS Total Score Change From Baseline to Week 6
Time frame: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.

2 secondary outcomes

MADRS Response
Time frame: 6 weeks
MADRS Remission
Time frame: 6 weeks

Results and safety

Results posted to the registry on 27 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD2066	40	20
Duloxetine	47	19
Placebo	44	19

Primary outcome: MADRS Total Score Change From Baseline to Week 6

Time frame: 6 weeks. Mean (Standard Deviation). Unit: scores on the scale

Measure	AZD2066 n = 39	Duloxetine n = 45	Placebo n = 40
Value	-13.1658 (2.11)	-14.0271 (1.97)	-14.1575 (2.16)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD2066	1 of 40 (2.5%)	21 of 40 (52.5%)	Not reported
Duloxetine	0 of 47 (0%)	30 of 47 (63.8%)	Not reported
Placebo	0 of 44 (0%)	16 of 44 (36.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

Recruiting
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Enrolling by invitation
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RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
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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.

Richard Malamut study chair

AstraZeneca

Lora McGill principal investigator

CNS Healthcare

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2066 and Duloxetine in people with Major Depressive Disorder, run by AstraZeneca at 13 sites in United States.

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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 27 Sep 2012). 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?

MADRS Total Score Change From Baseline to Week 6 (time frame: 6 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 NCT01145755.

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 3 Oct 2012.