Major Depressive DisorderPhase 2NCT01482221
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
A Phase 2 study testing AZD6765 iv in people with Major Depressive Disorder, run by AstraZeneca at 44 sites in 4 countries.
Trial summary
The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- AZD6765 iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 542 participants
- Where
- 44 sitesin 4 countries
- Study dates
- 16 Dec 2011to 26 Aug 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent before initiation of any study-related procedures.
- Male or female patients aged 18 to 70 years, inclusive.
- The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants.
- Women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start.
- Outpatient status at screening and randomization visits.
Who cannot join
- Patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
- Patients who have had a suicide attempt within the last 6 months.
- Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation.
- Patients with any history of seizure disorder (except for febrile seizures in childhood).
- Pregnancy or lactation.
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States33 sites
Research Site
Atlanta, Georgia
Research Site
Baltimore, Maryland
Research Site
Bellevue, Washington
Research Site
Boston, Massachusetts
Research Site
Chino, California
Research Site
Cincinnati, Ohio
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
Decatur, Georgia
Research Site
Fort Lauderdale, Florida
Research Site
Gainsville, Florida
Research Site
Hoffman Estates, Illinois
Research Site
Houston, Texas
Research Site
Joliet, Illinois
Research Site
Lake Charles, Louisiana
Research Site
Lake City, Florida
Research Site
Lond Beach, California
Research Site
Miami, Florida
Research Site
Minneapolis, Minnesota
Research Site
Mount Kisco, New York
Research Site
New Heaven, Connecticut
Research Site
New York, New York
Research Site
Orlando, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Rochester, New York
Research Site
San Diego, California
Research Site
Shreveport, Louisiana
Research Site
Skokie, Illinois
Research Site
St Louis, Missouri
Research Site
St. Petersburg, Florida
Research Site
Stanford, California
Research Site
Willingboro, New Jersey
Research Site
Winston-Salem, North Carolina
Slovakia6 sites
Research Site
Bratislava
Research Site
Liptovský Mikuláš
Research Site
Michalovce Stranany
Research Site
Rimavská Sobota
Research Site
Svidník
Research Site
Trnava
South Africa3 sites
Research Site
Cape Town
Research Site
Johannesburg
Research Site
Tygervalley
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients With Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants
The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.
Read the detailed description
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants
- Conditions
- Major Depressive Disorder
- Being tested
- AZD6765 iv, Placebo
- Keywords
- Major Depressive Disorder, MDD, Inadequate Response to Antidepressant Therapy, Channel blocker of the NMDA class of glutamate receptors
- 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.
AZD6765 ivDrug
50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.
AZD6765 ivDrug
100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.
PlaceboDrug
0.9 sodium chloride [normal saline] solution for injection by iv infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD6765 iv |
| 2 | Experimental | Not described Receives: Drug: AZD6765 iv |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Measured: Baseline to Week 6
Secondary outcomes (11)
Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Measured: Baseline to Week 12
Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12)
The percentage of patients with with Sustained Response (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12) was calculated.
Measured: Week 6 to Week 12
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6
The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
Measured: Baseline to Week 6
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12
The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
Measured: Baseline to Week 12
Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6
The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
Measured: Baseline to Week 6
Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12
The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
Measured: Baseline to Week 12
Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
A 3-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 intercorrelated domains (school/work, social life, and family life/home responsibilities), ranges from 0 (no impairment) to 30 (most severe impairment).
Measured: Baseline to Week 12
Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score
Clinical Global Impression - Severity (CGI-S) scale rates the severity of the patient's illness at the time of assessment, range from 1 (normal, not ill) to 7 (very severely ill).
Measured: Baseline to Week 12
Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 6
A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.
Measured: Baseline to Week 6
Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 12
A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.
Measured: Baseline to Week 12
Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score
A 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe).
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study start16 Dec 2011
- Primary completion26 Aug 2013
- Study completion26 Aug 2013
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
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dhaval A Desai, MD, Study director, 1800 Concord Pike, Wilmington, DE 19850
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482221
- Sponsor's protocol ID
- D6702C00031
- Other IDs
- EudraCT number 2011-004690-87
- Status last verified
- Apr 2017
- First submitted
- 28 Nov 2011
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients With Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants
- ClinicalTrials.gov ID
- NCT01482221
- Acronym / sponsor ID
- D6702C00031
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, Inadequate Response to Antidepressant Therapy, Channel blocker of the NMDA class of glutamate receptors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2011 (actual)
- Primary completion
- 26 Aug 2013 (actual)
- Study completion
- 26 Aug 2013 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.
Detailed description
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants
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 |
|---|---|---|
| 1 | Experimental | Drug: AZD6765 iv |
| 2 | Experimental | Drug: AZD6765 iv |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent before initiation of any study-related procedures.
- Male or female patients aged 18 to 70 years, inclusive.
- The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants.
- Women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start.
- Outpatient status at screening and randomization visits.
Key exclusion criteria (5 listed)
- Patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
- Patients who have had a suicide attempt within the last 6 months.
- Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation.
- Patients with any history of seizure disorder (except for febrile seizures in childhood).
- Pregnancy or lactation.
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 |
|---|---|---|
| AZD6765 iv50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion. | Drug | 1 |
| AZD6765 iv100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion. | Drug | 2 |
| Placebo0.9 sodium chloride [normal saline] solution for injection by iv infusion | Drug | 3 |
Primary outcome
Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to Week 6
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
11 secondary outcomes
Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to Week 12
Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12)
Time frame: Week 6 to Week 12
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6
Time frame: Baseline to Week 6
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12
Time frame: Baseline to Week 12
Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6
Time frame: Baseline to Week 6
Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12
Time frame: Baseline to Week 12
Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline to Week 12
Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline to Week 12
Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 6
Time frame: Baseline to Week 6
Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 12
Time frame: Baseline to Week 12
Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- D6702C00031\_Clinical Study Report\_SynopsisLink provided by the sponsor.
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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.
Dhaval A Desai, MD study director
1800 Concord Pike, Wilmington, DE 19850
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD6765 iv in people with Major Depressive Disorder, run by AstraZeneca at 44 sites in 4 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 5 inclusion and 5 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Slovakia, South Africa, Chile. 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 Apr 2017). 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?
Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2017.