TerminatedNCT01288079Updated Nov 20, 2012Results posted

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

A Phase 2 interventional study of TC-5214 and Duloxetine in Major Depressive Disorder, sponsored by AstraZeneca. Terminated at 67 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-11-20.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 145
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Major Depressive Disorder

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Keywords

Major Depressive Disorder
MDD
Monotherapy
Inadequate Response to Antidepressant Therapy

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 145 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 145 participants (actual)

Study arms

Experimental
1
TC-5214, 1 mg BID
Drug: TC-5214
Experimental
2
TC-5214, 4 mg BID
Drug: TC-5214
Active comparator
3
Duloxetine 60 mg Q Day
Drug: Duloxetine
Placebo comparator
4
Placebo
Drug: Placebo

Interventions

DrugTC-5214
Tablet, oral, twice daily for 8 weeks
DrugDuloxetine
Capsule, oral, once daily
DrugPlacebo
Tablet, oral, twice daily for 8 weeks

What researchers measure

Primary outcomes

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.
Time frame: Randomization (Week 8) to end of treatment (Week 16)

Results

Posted Oct 29, 2012

Limitations and caveats

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.

Participant flow

This multicenter study was conducted in Europe, Asia, and North America between 4 February 2011 and 26 April 2012.

Participant flow — Overall Study
Milestone	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo
Started	37	36	37	35
Completed	17	9	18	18
Not completed	20	27	19	17
Withdrew: Withdrawal by subject	2	4	1	0
Withdrew: Adverse event	2	1	2	3
Withdrew: Severe non-compliance to protocol	1	3	1	3
Withdrew: Condition under investigation worsened	0	0	0	1
Withdrew: Lack of efficacy	2	2	0	2
Withdrew: Study-specific withdrawal criteria	1	1	0	0
Withdrew: Lost to follow-up	1	1	1	0
Withdrew: Other or study termination	11	15	14	8

Outcome measures

PrimaryChange 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.

Time frame:: Randomization (Week 8) to end of treatment (Week 16)
Reported as:: Least squares mean · units on a scale

Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment
units on a scale	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo
Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment	-9.1 ± 2.15	-11.2 ± 2.56	-11.4 ± 2.14	-7.6 ± 2.19

Statistical analysis

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

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1 mg BID TC-5214	—	1/37 (2.7%)	22/37 (59.5%)
4 mg BID TC-5214	—	0/35 (0%)	27/35 (77.1%)
60 mg QD Duloxetine	—	0/37 (0%)	21/37 (56.8%)
Placebo	—	1/35 (2.9%)	24/35 (68.6%)

Most frequent serious events

Most frequent serious events
Event	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo
Abdominal PainGastrointestinal disorders	0/37	0/35	0/37	1/35
Subcutaneous AbscessInfections and infestations	1/37	0/35	0/37	0/35

Most frequent other events

Showing 10 of 96

Most frequent other events
Event	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo
ConstipationGastrointestinal disorders	0/37	9/35	2/37	2/35
NauseaGastrointestinal disorders	4/37	3/35	7/37	2/35
DizzinessNervous system disorders	6/37	4/35	5/37	6/35
HeadacheNervous system disorders	4/37	6/35	3/37	5/35
InfluenzaInfections and infestations	1/37	1/35	2/37	4/35
SomnolenceNervous system disorders	2/37	1/35	4/37	0/35
InsomniaPsychiatric disorders	0/37	3/35	4/37	2/35
DiarrhoeaGastrointestinal disorders	1/37	3/35	1/37	3/35
NasopharyngitisInfections and infestations	3/37	2/35	0/37	3/35
Increased AppetiteMetabolism and nutrition disorders	0/37	0/35	0/37	3/35

Baseline characteristics

Age Continuous
Age Continuous(years)	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo	Total
Mean	44.5 ± 13.03	40.3 ± 12.50	41.8 ± 12.70	40.1 ± 10.49	41.7 ± 12.24

Sex: Female, Male
Sex: Female, Male(Participants)	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo	Total
Female	24	26	22	19	91
Male	13	10	15	16	54

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo	Total
White	23	20	23	20	86
Black or African American	1	4	4	5	14
Asian	12	10	9	9	40
Native Hawaiian or other Pacific Islander	0	0	0	0	0
American Indian or Alaska Native	0	0	0	0	0
Other	1	2	1	1	5

Hamilton Rating Scale for Depression-17 items (HAMD-17) total score at randomization
Hamilton Rating Scale for Depression-17 items (HAMD-17) total score at randomization(Scores on a scale)	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo	Total
Mean	20.914 ± 3.425	21.371 ± 3.606	21.857 ± 3.499	21.344 ± 4.100	21.372 ± 3.632

Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization
Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization(Scores on a scale)	1 mg BID TC-5214	4 mg BID TC-5214	60 mg QD Duloxetine	Placebo	Total
Mean	27.228 ± 5.202	26.857 ± 5.542	28.600 ± 6.796	27.625 ± 5.320	27.577 ± 5.734

Study locations

67 sites

Research Site
Beverly Hills, California, United States
Research Site
Chino, California, United States
Research Site
Garden Grove, California, United States
Research Site
San Diego, California, United States
Research Site
Torrance, California, United States
Research Site
Bradenton, Florida, United States
Research Site
Coral Springs, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
North Miami, Florida, United States
Research Site
St Petersburg, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Joliet, Illinois, United States
Research Site
Prairie Village, Kansas, United States
Research Site
Flowood, Mississippi, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Dayton, Ohio, United States
Research Site
Mason, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Allentown, Pennsylvania, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Seattle, Washington, United States
Research Site
Madison, Wisconsin, United States
Research Site
Tallinn, Estonia
Research Site
Tallin, Estonia
Research Site
Tartu, Estonia
Research Site
Helsinki, Finland
Research Site
Jyväskylä, Finland
Research Site
Kuopio, Finland
Research Site
Tampere, Finland
Research Site
Visakhapatnam, Andh Prad, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Bangalore, Kamataka, India
Research Site
Bangalore, Karnataka, India
Research Site
Mangalore, Karnataka, India
Research Site
Nashik, Mahara, India
Research Site
Jaipur, Rajasthan, India
Research Site
Chennai, Tamil Nadu, India
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Varanasi, Uttar Prad, India
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Kanpur, India
Research Site
Pune, India
Research Site
Nagoya, Aichi, Japan
Research Site
Ichikawa, Chiba, Japan
Research Site
Noda City, Chiba, Japan
Research Site
Fukuoka-city, Fukuoka, Japan
Research Site
Omuta-City, Fukuoka, Japan
Research Site
Sapporo-shi, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Sapproro, Hokkaido, Japan
Research Site
Akashi, Hyogo, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Kawasaki-shi, Kanagawa, Japan
Research Site
Sagamihara-shi, Kanagawa, Japan
Research Site
Yokohama-city, Kanagawa, Japan
Research Site
Yokohama-shi, Kanagawa, Japan
Research Site
Yatsushiro-city, Kumamoto, Japan
Research Site
Yatsushiro, Kumamoto, Japan
Research Site
Ukyo-ku ,Kyoto, Kyoto, Japan
Research Site
Kurashiki-shi, Okayama, Japan
Research Site
Kodaira-shi, Tokyo, Japan
Research Site
Meguro-ku, Tokyo, Japan
Research Site
Minato-ku, Tokyo, Japan
Research Site
Setagaya-ku, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Kumamoto, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01288079
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Feb 2, 2011
Start date: Feb 2011
Primary completion: Aug 2012
Completion: Aug 2012
Results posted: Oct 29, 2012
Last update: Nov 20, 2012

Study contacts

Hans A Eriksson, MD, PhD, MBA

study director · AstraZeneca R&D Södertälje

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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