Major Depressive DisorderPhase 3NCT01152554

A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

A Phase 3 study testing TC-5214 in people with Major Depressive Disorder and MDD, run by AstraZeneca at 94 sites in 2 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken for 52 weeks with another antidepressant medicine. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder, MDD, Depression
What is being tested?: TC-5214
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 813 participants
Where: 94 sitesin 2 countries
Study dates: Jun 2010to Feb 2012
Phase: Phase 3
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.
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 significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.

Trial locations and contacts

94 sites in 2 countries.

Country

City, postcode or hospital

94 sites in 2 countries

United States93 sites

Research Site
Albuquerque, New Mexico
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Arcadia, California
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Austin, Texas
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Baltimore, Maryland
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Beechwood, Ohio
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Beverly Hills, California
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Birmingham, Alabama
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Bradenton, Florida
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Canton, Ohio
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Carson, California
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Cerritos, California
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Charleston, South Carolina
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Charlotte, North Carolina
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Chicago, Illinois
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Chino, California
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Coral Springs, Florida
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Costa Mesa, California
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Creve Coeur, Missouri
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Dallas, Texas
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Dayton, Ohio
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Denver, Colorado
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Dublin, Ohio
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Encino, California
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Escondido, California
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Florence, Kentucky
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Flowood, Mississippi
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Fort Myers, Florida
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Fresh Meadows, New York
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Friendswood, Texas
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Gainsville, Florida
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Gaithersburg, Maryland
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Garden Grove, California
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Glen Burnie, Maryland
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Hoffman Estates, Illinois
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Irvine, California
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Irving, Texas
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Jacksonville, Florida
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Jenkintown, Pennsylvania
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Joliet, Illinois
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Lafayette, Indiana
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Lake Jackson, Texas
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Lincoln, Nebraska
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Little Rock, Arkansas
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Los Alamitos, California
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Los Angeles, California
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Maitland, Florida
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Mason, Ohio
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Middleburg Heights, Ohio
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Middleton, Wisconsin
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Mount Kisco, New York
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New York, New York
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Newport Beach, California
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Norristown, Pennsylvania
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North Miami, Florida
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Norwalk, Connecticut
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Norwich, Connecticut
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Orange City, Florida
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Orlando, Florida
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Pico Rivera, California
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Pinecrest, Florida
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Pittsburgh, Pennsylvania
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Plantation, Florida
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Portland, Oregon
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Prairie Village, Kansas
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Riverside, California
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Rochester, New York
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Rockville, Maryland
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Roswell, Georgia
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Salem, Oregon
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San Antonio, Texas
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Schaumburg, Illinois
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Seattle, Washington
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Sherman Oaks, California
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Shreveport, Louisiana
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Skokie, Illinois
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South Kirkland, Washington
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St Louis, Missouri
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St. Petersburg, Florida
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Staten Island, New York
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Tampa, Florida
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Toledo, Ohio
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Toms River, New Jersey
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Torrance, California
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Tucson, Arizona
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Tuscaloosa, Alabama
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Upland, California
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Valparaiso, Indiana
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West Palm Beach, Florida
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Weymouth, Massachusetts
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Wichita, Kansas
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Willingboro, New Jersey
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Wilmington, North Carolina
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Woodstock, Vermont

Other trials in United States

Puerto Rico1 site

Research Site
San Juan

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Conditions: Major Depressive Disorder, MDD, Depression
Being tested: TC-5214, Placebo
Keywords: Major Depressive Disorder, MDD, Depression, Safety, add-on therapy
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.

TC-5214Drug
Tablet, oral, twice daily for 52 weeks
PlaceboDrug
Tablet, oral, twice daily for 52 weeks

Study groups in NCT01152554
Study group	Role	What they receive
SSRI/Serotonin/SNRI + TC-5214 1-4 mg	Experimental	Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID Receives: Drug: TC-5214
SSRI/Serotonin/SNRI + placebo	Placebo comparator	Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID Receives: Drug: Placebo

What is being measured

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

Frequency of Patients Experiencing at Least One Adverse Event (AE)
The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
Measured: Randomization (Week 0) to end of the follow-up period (Week 54)
Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Measured: Randomization (Week 0) to end of the follow-up period (Week 54)
Frequency of Patients Experiencing Serious Adverse Events (SAEs)
The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.
Measured: Randomization (Week 0) to end of the follow-up period (Week 54)

Secondary outcomes (6)

Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24
The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20.
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: Week 12 to Week 24
Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52
The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48.
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: Week 12 to Week 52
Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)
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. Higher CGI-S scores indicate greater illness severity.
Measured: Randomization (Week 0) to end of treatment (Week 52)
Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score
Sheehan Disability Scale (SDS) is 5-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 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).
Measured: Randomization (Week 0) to end of treatment (Week 52)
Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score
The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.
Measured: Randomization (Week 0) to end of treatment (Week 52)
Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)
A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.
Measured: Randomization (Week 0) to end of treatment (Week 52)

Timeline

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

Jun 2010Feb 2012

First posted29 Jun 2010 (estimated)
Study startJun 2010
Primary completionFeb 2012
Study completionFeb 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.
Publications (1)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 813 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152554
Sponsor's protocol ID: D4130C00007
Status last verified: Mar 2014
First submitted: 28 Jun 2010
Last updated: 11 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tummala R, Desai D, Szamosi J, Wilson E, Hosford D, Dunbar G, Eriksson H. Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study. J Clin Psychopharmacol. 2015 Feb;35(1):77-81. doi: 10.1097/JCP.0000000000000269.
PubMed 25514064

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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2014. 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 III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
ClinicalTrials.gov ID: NCT01152554
Acronym / sponsor ID: D4130C00007
Conditions: Major Depressive Disorder, MDD, Depression
Keywords: Major Depressive Disorder, MDD, Depression, Safety, add-on therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 813 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Targacept Inc.
Study start: Jun 2010
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 29 Jun 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SSRI/Serotonin/SNRI + TC-5214 1-4 mg	Experimental	Drug: TC-5214Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID
SSRI/Serotonin/SNRI + placebo	Placebo comparator	Drug: PlaceboSelective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID

Who may qualify

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

Key inclusion criteria (3 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.
Outpatient status at enrollment and randomization.

Key exclusion criteria (3 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 significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.

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 52 weeks	Drug	SSRI/Serotonin/SNRI + TC-5214 1-4 mg
PlaceboTablet, oral, twice daily for 52 weeks	Drug	SSRI/Serotonin/SNRI + placebo

Primary outcome

Frequency of Patients Experiencing at Least One Adverse Event (AE)
Time frame: Randomization (Week 0) to end of the follow-up period (Week 54)
The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
Time frame: Randomization (Week 0) to end of the follow-up period (Week 54)
The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Frequency of Patients Experiencing Serious Adverse Events (SAEs)
Time frame: Randomization (Week 0) to end of the follow-up period (Week 54)
The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.

6 secondary outcomes

Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24
Time frame: Week 12 to Week 24
Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52
Time frame: Week 12 to Week 52
Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)
Time frame: Randomization (Week 0) to end of treatment (Week 52)
Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score
Time frame: Randomization (Week 0) to end of treatment (Week 52)
Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score
Time frame: Randomization (Week 0) to end of treatment (Week 52)
Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)
Time frame: Randomization (Week 0) to end of treatment (Week 52)

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
TC-5214	610	276
Placebo	203	92

Primary outcome: Frequency of Patients Experiencing at Least One Adverse Event (AE)

Time frame: Randomization (Week 0) to end of the follow-up period (Week 54). Number. Unit: percentage of participants analyzed

Measure	TC-5214 n = 607	Placebo n = 201
Value	82.4	84.6

Population analysed: Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.

Primary outcome: Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)

Time frame: Randomization (Week 0) to end of the follow-up period (Week 54). Number. Unit: percentage of participants analyzed

Measure	TC-5214 n = 607	Placebo n = 201
Value	10.5	7.0

Population analysed: Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.

Primary outcome: Frequency of Patients Experiencing Serious Adverse Events (SAEs)

Time frame: Randomization (Week 0) to end of the follow-up period (Week 54). Number. Unit: percentage of participants analyzed

Measure	TC-5214 n = 607	Placebo n = 201
Value	3.6	2.5

Population analysed: Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 201 (2.5%)	151 of 201 (75.1%)	Not reported
TC-5214	22 of 607 (3.6%)	451 of 607 (74.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25514064Tummala R, Desai D, Szamosi J, Wilson E, Hosford D, Dunbar G, Eriksson H. Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study. J Clin Psychopharmacol. 2015 Feb;35(1):77-81. doi: 10.1097/JCP.0000000000000269.
CSR-D4130C00007.pdfLink provided by the sponsor.
D4130C00007/Clinical Study ProtocolLink 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.

Hans A. Eriksson, MD, Ph.D, MBA study director

AstraZeneca

Andrew . J Cutler, MD principal investigator

Florida Clinical Research Center, LLC

94 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TC-5214 in people with Major Depressive Disorder and MDD, run by AstraZeneca at 94 sites in 2 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 3 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Frequency of Patients Experiencing at Least One Adverse Event (AE) (time frame: Randomization (Week 0) to end of the follow-up period (Week 54)). The study lists 3 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 NCT01152554, 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 11 Apr 2014.