Major Depressive DisorderPhase 2NCT00781742
AZD6765 Severe Major Depressive Disorder (MDD) IV
A Phase 2 study testing AZD6765 in people with Major Depressive Disorder, run by AstraZeneca at 27 sites in United States.
Trial summary
The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression… 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?
- AZD6765
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 27 sitesUnited States
- Study dates
- Oct 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Signed informed consent before any study-related procedures start.
- The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
- Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.
Who cannot join
- Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
- Patient has a lifetime history of failure to ECT therapy.
- Patient is pregnant or breast feeding.
- Length of current episode of depression exceeds ≥2 years.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Research Site
Albuquerque, New Mexico
Research Site
Atlanta, Georgia
Research Site
Austin, Texas
Research Site
Boca Raton, Florida
Research Site
Dallas, Texas
Research Site
East Stroudsburg, Pennsylvania
Research Site
Gainsville, Florida
Research Site
Hartford, Connecticut
Research Site
Haverhill, Massachusetts
Research Site
Hoffman Estates, Illinois
Research Site
Hollywood, Florida
Research Site
Jacksonville, Florida
Research Site
Joliet, Illinois
Research Site
Lake Charles, Louisiana
Research Site
Little Rock, Arkansas
Research Site
Los Angeles, California
Research Site
New Haven, Connecticut
Research Site
Orange, California
Research Site
Overland Park, Kansas
Research Site
Philadelphia, Pennsylvania
Research Site
Rochester, New York
Research Site
Roswell, Georgia
Research Site
San Diego, California
Research Site
Santa Ana, California
Research Site
Shreveport, Louisiana
Research Site
St Louis, Missouri
Research Site
Willingboro, New Jersey
About this study
Official title: A Phase IIb, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Efficacy and Safety Study of Adjunctive AZD6765 in Subjects With Severe Major Depressive Disorder (MDD) and a History of Poor Response to Antidepressants
The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).
- Conditions
- Major Depressive Disorder
- Being tested
- AZD6765, Placebo
- Keywords
- Depression, Depressive Disorder, MDD
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6765Drug
IV once per dosing day, multiple times during the treatment period
PlaceboDrug
0.9% saline IV once per dosing day multiple times during the treatment period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 100 mg iv once per dosing day Receives: Drug: AZD6765 |
| 2 | Experimental | 150 mg iv once per dosing day Receives: Drug: AZD6765 |
| 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.
To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score
Measured: Baseline to week 3
Secondary outcomes (3)
To determine if the antidepressant effect can be achieved at week 3 with AZD6765 (100 or 150 mg/infusion) versus placebo by assessing a change from baseline to week 3 in the MADRS total score.
Measured: 3 weeks
To evaluate the rapid antidepressant efficacy of AZD6765 at 1 day after a first infusion, as assessed by a change in the Quick Inventory of Depressive Symptomology Self-Report 16-item scale (QIDS-SR-16) total score.
Measured: baseline to Day 1
• To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Castiglione, Study director, AstraZenecaGerard Sanacora, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781742
- Sponsor's protocol ID
- D6702C00009
- Status last verified
- Jul 2012
- First submitted
- 27 Oct 2008
- Last updated
- 25 Jul 2012
- Results posted
- No
Publications
Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
PubMed 34510411Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.
PubMed 24126931
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Efficacy and Safety Study of Adjunctive AZD6765 in Subjects With Severe Major Depressive Disorder (MDD) and a History of Poor Response to Antidepressants
- ClinicalTrials.gov ID
- NCT00781742
- Acronym / sponsor ID
- D6702C00009
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Depressive Disorder, MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 29 Oct 2008 (estimated)
- Results
- Not posted in the source record
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 research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).
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: AZD6765100 mg iv once per dosing day |
| 2 | Experimental | Drug: AZD6765150 mg iv once per dosing day |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent before any study-related procedures start.
- The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
- Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.
Key exclusion criteria (4 listed)
- Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
- Patient has a lifetime history of failure to ECT therapy.
- Patient is pregnant or breast feeding.
- Length of current episode of depression exceeds ≥2 years.
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 |
|---|---|---|
| AZD6765IV once per dosing day, multiple times during the treatment period | Drug | 1, 2 |
| Placebo0.9% saline IV once per dosing day multiple times during the treatment period | Drug | 3 |
Primary outcome
To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score
Time frame: Baseline to week 3
3 secondary outcomes
To determine if the antidepressant effect can be achieved at week 3 with AZD6765 (100 or 150 mg/infusion) versus placebo by assessing a change from baseline to week 3 in the MADRS total score.
Time frame: 3 weeks
To evaluate the rapid antidepressant efficacy of AZD6765 at 1 day after a first infusion, as assessed by a change in the Quick Inventory of Depressive Symptomology Self-Report 16-item scale (QIDS-SR-16) total score.
Time frame: baseline to Day 1
• To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
- Derived from this study: PubMed 34510411Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
- Derived from this study: PubMed 24126931Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.
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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.
Michael Castiglione study director
AstraZeneca
Gerard Sanacora principal investigator
Yale University
27 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 AZD6765 in people with Major Depressive Disorder, run by AstraZeneca at 27 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 3 inclusion and 4 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 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (time frame: Baseline to week 3). 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 NCT00781742, which also lists 2 linked publications.
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 25 Jul 2012.