Major Depressive DisorderPhase 2NCT01020799

AZD7268 Safety and Tolerability Study

A Phase 2 study testing AZD7268 and Escitalopram in people with Major Depressive Disorder, run by AstraZeneca at 17 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo. 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?: AZD7268 and Escitalopram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 247 participants
Where: 17 sitesUnited States
Study dates: Nov 2009to Apr 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 prior to any study specific procedures
Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
296.2x Major Depressive Disorder, Single Episode, or
296.3x Major Depressive Disorder, Recurrent

Who cannot join

Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
Patients whose current episode of depression started less than 4 weeks before enrollment

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Research Site
Atlanta, Georgia
Research Site
Bellevue, Washington
Research Site
Birmingham, Alabama
Research Site
Bradenton, Florida
Research Site
Cedarhurst, New York
Research Site
Dayton, Ohio
Research Site
Friendswood, Texas
Research Site
Garden Grove, California
Research Site
Jacksonville, Florida
Research Site
Memphis, Tennessee
Research Site
New Haven, Connecticut
Research Site
New York, New York
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 II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder

The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.

Conditions: Major Depressive Disorder
Being tested: AZD7268, Escitalopram, Placebo capsules, Placebo tablets
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.

AZD7268Drug
15 mg, oral, twice daily (BID)
EscitalopramDrug
20 mg, oral, once daily (QD)
Placebo capsulesDrug
Placebo capsules to match AZD7268
Placebo tabletsDrug
Placebo tablets to match encapsulated escitalopram

Study groups in NCT01020799
Study group	Role	What they receive
AZD7268	Experimental	The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only. Receives: Drug: AZD7268; Drug: Placebo tablets
Placebo	Placebo comparator	The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only. Receives: Drug: Placebo capsules; Drug: Placebo tablets
Escitalopram	Active comparator	The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only. Receives: Drug: Escitalopram; Drug: Placebo capsules

What is being measured

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

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Measured: Baseline, Week 4

Secondary outcomes (5)

Montgomery-Åsberg Depression Rating Scale (MADRS) Response
Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]
Measured: Week 4
Montgomery-Åsberg Depression Rating Scale (MADRS) Remission
Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]
Measured: Week 4
Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.
HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Measured: Baseline, Week 4
Clinical Global Impression - Severity (CGI-S) Score Change From Baseline
CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 ("Normal, not ill") to 7 ("Among the most extremely ill patients"). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Measured: Baseline, Week 4
Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline
HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Measured: Baseline, Week 4

Timeline

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

Nov 2009Apr 2010

First posted26 Nov 2009 (estimated)
Study startNov 2009
Primary completionApr 2010
Study completionApr 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: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01020799
Sponsor's protocol ID: D1151C00005
Status last verified: Apr 2012
First submitted: 25 Nov 2009
Last updated: 17 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

All Major Depressive Disorder trials

Study at a glance

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

Official title: A Phase II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01020799
Acronym / sponsor ID: D1151C00005
Conditions: Major Depressive Disorder
Keywords: Depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 26 Nov 2009 (estimated)
Results: Posted 10 Apr 2012

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 prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.

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
AZD7268	Experimental	Drug: AZD7268, Drug: Placebo tabletsThe AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only.
Placebo	Placebo comparator	Drug: Placebo capsules, Drug: Placebo tabletsThe placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only.
Escitalopram	Active comparator	Drug: Escitalopram, Drug: Placebo capsulesThe escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.

Who may qualify

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

Key inclusion criteria (4 listed)

Provision of signed, written, and dated Informed Consent prior to any study specific procedures
Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
296.2x Major Depressive Disorder, Single Episode, or
296.3x Major Depressive Disorder, Recurrent

Key exclusion criteria (3 listed)

Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
Patients whose current episode of depression started less than 4 weeks before enrollment

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
AZD726815 mg, oral, twice daily (BID)	Drug	AZD7268
Escitalopram20 mg, oral, once daily (QD)	Drug	Escitalopram
Placebo capsulesPlacebo capsules to match AZD7268	Drug	Escitalopram, Placebo
Placebo tabletsPlacebo tablets to match encapsulated escitalopram	Drug	AZD7268, Placebo

Primary outcome

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
Time frame: Baseline, Week 4
MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]

5 secondary outcomes

Montgomery-Åsberg Depression Rating Scale (MADRS) Response
Time frame: Week 4
Montgomery-Åsberg Depression Rating Scale (MADRS) Remission
Time frame: Week 4
Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.
Time frame: Baseline, Week 4
Clinical Global Impression - Severity (CGI-S) Score Change From Baseline
Time frame: Baseline, Week 4
Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline
Time frame: Baseline, Week 4

Results and safety

Results posted to the registry on 10 Apr 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
AZD7268	98	79
Placebo	99	85
Escitalopram	50	43

Primary outcome: Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.

Time frame: Baseline, Week 4. Least squares mean (Standard Error). Unit: scores on a scale

Measure	AZD7268 n = 91	Placebo n = 94	Escitalopram n = 49
Value	-11.78 (1.13)	-11.45 (1.05)	-11.70 (1.57)

5 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
AZD7268	0 of 96 (0%)	36 of 96 (37.5%)	Not reported
Placebo	0 of 99 (0%)	33 of 99 (33.3%)	Not reported
Escitalopram	0 of 50 (0%)	26 of 50 (52%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

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.

The record lists no contact. Use the official record to reach the sponsor.

17 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 AZD7268 and Escitalopram in people with Major Depressive Disorder, run by AstraZeneca at 17 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 4 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 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 10 Apr 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?

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4. (time frame: Baseline, Week 4). 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 NCT01020799.

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 Apr 2012.