Anxious Major Depressive DisorderPhase 2NCT00759395
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
A Phase 2 study testing AZD2327 in people with Anxious Major Depressive Disorder, run by AstraZeneca at 1 site in United States.
Trial summary
This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxious Major Depressive Disorder
- What is being tested?
- AZD2327
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2011
- 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 informed consent prior to any study specific procedures
- Diagnosis of major depressive disorder without psychotic features (MDD)
Who cannot join
- A history of substance or alcohol abuse within the past 6 months or dependence within 1 year of enrollment as defined by DSM-IV criteria.
- Women that are pregnant or lactating
- History of pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder
This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.
- Conditions
- Anxious Major Depressive Disorder
- Being tested
- AZD2327, Placebo
- Keywords
- Anxious Major Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2327Drug
Tablet, Oral, Daily
PlaceboDrug
Tablet, Oral, Daily
| Study group | Role | What they receive |
|---|---|---|
| AZD2327 | Experimental | AZD2327 3mg BID Receives: Drug: AZD2327 |
| Placebo | Placebo comparator | Placebo BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D) Total Score.
Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Measured: Week 4
Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Measured: Week 4
Secondary outcomes (3)
Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome.
Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Measured: Week 4
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score.
Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Measured: Randomization to week 4
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.
Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in HAM-A total score.
The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Measured: Randomization to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionOct 2011
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 Anxious 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Smith, MD, Study director, AstraZenecaCarlos Zarate, Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759395
- Sponsor's protocol ID
- D0880C00021
- Status last verified
- Oct 2012
- First submitted
- 24 Sep 2008
- Last updated
- 8 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Richards EM, Mathews DC, Luckenbaugh DA, Ionescu DF, Machado-Vieira R, Niciu MJ, Duncan WC, Nolan NM, Franco-Chaves JA, Hudzik T, Maciag C, Li S, Cross A, Smith MA, Zarate CA Jr. A randomized, placebo-controlled pilot trial of the delta opioid receptor agonist AZD2327 in anxious depression. Psychopharmacology (Berl). 2016 Mar;233(6):1119-30. doi: 10.1007/s00213-015-4195-4. Epub 2016 Jan 4.
PubMed 26728893
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00759395
- Acronym / sponsor ID
- D0880C00021
- Conditions
- Anxious Major Depressive Disorder
- Keywords
- Anxious Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 8 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD2327 | Experimental | Drug: AZD2327AZD2327 3mg BID |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo BID |
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 informed consent prior to any study specific procedures
- Diagnosis of major depressive disorder without psychotic features (MDD)
Key exclusion criteria (3 listed)
- A history of substance or alcohol abuse within the past 6 months or dependence within 1 year of enrollment as defined by DSM-IV criteria.
- Women that are pregnant or lactating
- History of pancreatitis
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 |
|---|---|---|
| AZD2327Tablet, Oral, Daily | Drug | AZD2327 |
| PlaceboTablet, Oral, Daily | Drug | Placebo |
Primary outcome
Hamilton Rating Scale for Depression (HAM-D) Total Score.
Time frame: Week 4
Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
Time frame: Week 4
The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
3 secondary outcomes
Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
Time frame: Week 4
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
Time frame: Randomization to week 4
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.
Time frame: Randomization to week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26728893Richards EM, Mathews DC, Luckenbaugh DA, Ionescu DF, Machado-Vieira R, Niciu MJ, Duncan WC, Nolan NM, Franco-Chaves JA, Hudzik T, Maciag C, Li S, Cross A, Smith MA, Zarate CA Jr. A randomized, placebo-controlled pilot trial of the delta opioid receptor agonist AZD2327 in anxious depression. Psychopharmacology (Berl). 2016 Mar;233(6):1119-30. doi: 10.1007/s00213-015-4195-4. Epub 2016 Jan 4.
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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.
Mark Smith, MD study director
AstraZeneca
Carlos Zarate principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD2327 in people with Anxious Major Depressive Disorder, run by AstraZeneca at 1 site 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: finished, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 Nov 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?
Hamilton Rating Scale for Depression (HAM-D) Total Score. (time frame: Week 4). The study lists 2 primary outcomes in all. 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 NCT00759395, 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 8 Nov 2012.