Major Depressive DisorderPhase 2NCT01288079

A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

A Phase 2 study testing TC-5214 and Duloxetine in people with Major Depressive Disorder, run by AstraZeneca at 63 sites in 5 countries.

Terminated

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

Official record

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Trial summary

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants. 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?: TC-5214 and Duloxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 145 participants
Where: 63 sitesin 5 countries
Study dates: Feb 2011to Aug 2012
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 and dated informed consent before initiation of any study-related procedures.
The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
Outpatient status at enrollment and randomization.

Who cannot join

Patients with a lifetime history of bipolar disorder; psychotic disorder or post-traumatic stress disorder.
Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
Pregnancy or lactation.

Trial locations and contacts

63 sites in 5 countries.

Country

City, postcode or hospital

63 sites in 5 countries

United States25 sites

Research Site
Allentown, Pennsylvania
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Atlanta, Georgia
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Beverly Hills, California
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Bradenton, Florida
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Chino, California
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Coral Springs, Florida
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Dallas, Texas
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Dayton, Ohio
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Flowood, Mississippi
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Garden Grove, California
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Houston, Texas
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Jacksonville, Florida
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Joliet, Illinois
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Madison, Wisconsin
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Mason, Ohio
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New York, New York
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North Miami, Florida
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Portland, Oregon
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Prairie Village, Kansas
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Rochester, New York
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San Diego, California
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Seattle, Washington
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St. Petersburg, Florida
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Torrance, California
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West Palm Beach, Florida

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Japan21 sites

Research Site
Akashi, Hyōgo
Research Site
Fukuoka, Fukuoka
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Ichikawa, Chiba
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Kawasaki-shi, Kanagawa
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Kobe, Hyōgo
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Kodaira-shi, Tokyo
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Kumamoto, Kumamoto
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Kurashiki-shi, Okayama-ken
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Meguro-ku, Tokyo
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Minato-ku, Tokyo
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Nagoya, Aichi-ken
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Noda, Chiba
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Omuta, Fukuoka
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Sagamihara-shi, Kanagawa
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Sapporo, Hokkaido
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Sapproro, Hokkaido
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Setagaya-ku, Tokyo
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Shinagawa-ku, Tokyo
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Ukyo-ku ,Kyoto, Kyoto
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Yatsushiro, Kumamoto
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Yokohama, Kanagawa

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India11 sites

Research Site
Ahmedabad, Gujarat
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Bangalore, Kamataka
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Bangalore, Karnataka
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Chennai, Tamil Nadu
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Jaipur, Rajasthan
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Kanpur
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Mangalore, Karnataka
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Nashik, Mahara
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Pune
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Varanasi, Uttar Prad
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Visakhapatnam, Andh Prad

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Finland4 sites

Research Site
Helsinki
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Jyväskylä
Research Site
Kuopio
Research Site
Tampere

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Estonia2 sites

Research Site
Tallinn
Research Site
Tartu

Other trials in Estonia

About this study

Official title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Conditions: Major Depressive Disorder
Being tested: TC-5214, Duloxetine, Placebo
Keywords: Major Depressive Disorder, MDD, Monotherapy, Inadequate Response to Antidepressant Therapy
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.

TC-5214Drug
Tablet, oral, twice daily for 8 weeks
DuloxetineDrug
Capsule, oral, once daily
PlaceboDrug
Tablet, oral, twice daily for 8 weeks

Study groups in NCT01288079
Study group	Role	What they receive
1	Experimental	TC-5214, 1 mg BID Receives: Drug: TC-5214
2	Experimental	TC-5214, 4 mg BID Receives: Drug: TC-5214
3	Active comparator	Duloxetine 60 mg Q Day Receives: Drug: Duloxetine
4	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment
A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (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: Randomization (Week 8) to end of treatment (Week 16)

Timeline

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

Feb 2011Aug 2012

First posted2 Feb 2011 (estimated)
Study startFeb 2011
Primary completionAug 2012
Study completionAug 2012

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01288079
Sponsor's protocol ID: D4131C00001
Status last verified: Nov 2012
First submitted: 26 Jan 2011
Last updated: 20 Nov 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

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
ClinicalTrials.gov ID: NCT01288079
Acronym / sponsor ID: D4131C00001
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, MDD, Monotherapy, Inadequate Response to Antidepressant Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 145 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 2 Feb 2011 (estimated)
Results: Posted 29 Oct 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 assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: TC-5214TC-5214, 1 mg BID
2	Experimental	Drug: TC-5214TC-5214, 4 mg BID
3	Active comparator	Drug: DuloxetineDuloxetine 60 mg Q Day
4	Placebo comparator	Drug: PlaceboPlacebo

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 and dated informed consent before initiation of any study-related procedures.
The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
Outpatient status at enrollment and randomization.

Key exclusion criteria (5 listed)

Patients with a lifetime history of bipolar disorder; psychotic disorder or post-traumatic stress disorder.
Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
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
TC-5214Tablet, oral, twice daily for 8 weeks	Drug	1, 2
DuloxetineCapsule, oral, once daily	Drug	3
PlaceboTablet, oral, twice daily for 8 weeks	Drug	4

Primary outcome

Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment
Time frame: Randomization (Week 8) to end of treatment (Week 16)
A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (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.

Results and safety

Results posted to the registry on 29 Oct 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
1 mg BID TC-5214	37	17
4 mg BID TC-5214	36	9
60 mg QD Duloxetine	37	18
Placebo	35	18

Primary outcome: Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment

Time frame: Randomization (Week 8) to end of treatment (Week 16). Least squares mean (Standard Error). Unit: units on a scale

Measure	1 mg BID TC-5214 n = 35	4 mg BID TC-5214 n = 35	60 mg QD Duloxetine n = 35	Placebo n = 32
Value	-9.1 (2.15)	-11.2 (2.56)	-11.4 (2.14)	-7.6 (2.19)

1 mg BID TC-5214 vs Placebo: LS mean: -1.5 (95% CI -7.35 to 4.39), p = 0.617, MMRM
4 mg BID TC-5214 vs Placebo: LS mean: -3.6 (95% CI -10.06 to 2.91), p = 0.277, MMRM
60 mg QD Duloxetine vs Placebo: LS mean: -3.9 (95% CI -9.72 to 2.00), p = 0.194, MMRM

Population analysed: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214, duloxetine or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 mg BID TC-5214	1 of 37 (2.7%)	22 of 37 (59.5%)	Not reported
4 mg BID TC-5214	0 of 35 (0%)	27 of 35 (77.1%)	Not reported
60 mg QD Duloxetine	0 of 37 (0%)	21 of 37 (56.8%)	Not reported
Placebo	1 of 35 (2.9%)	24 of 35 (68.6%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early and thus only a fraction of the planned number of patients were randomized and many did not complete the study. As a consequence the possibility of interpreting efficacy over an 8 week period is considerably reduced.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Hans A Eriksson, MD, PhD, MBA study director

AstraZeneca R&D Södertälje

63 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TC-5214 and Duloxetine in people with Major Depressive Disorder, run by AstraZeneca at 63 sites in 5 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 4 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: stopped early, as of the sponsor's last update on 20 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 63 sites in United States, Japan, India, Finland, Estonia. 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 29 Oct 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?

Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment (time frame: Randomization (Week 8) to end of treatment (Week 16)). 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 NCT01288079.

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 20 Nov 2012.