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

NCT01197508 | Completed Phase 3 Results

• 1 other identifier: D4130C00005
• Study Type: interventional
• Target: 696
• Locations: 17 countries
• Sites: 87

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder, MDD, Depression

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Randomization (Week 8) to end of treatment (Week 16)

Secondary Outcomes (21)

• Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)

  Randomization (Week 8) to end of treatment (Week 16)

• Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)

  Week 16

• Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)

  Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16

• Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)

  Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16

• Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)

  Week 12, Week 14, Week 16

Study Arms (4)

0.1 mg BID TC-5214

EXPERIMENTAL

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID

Drug: TC-5214

1 mg BID TC-5214

EXPERIMENTAL

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID

Drug: TC-5214

4 mg BID TC-5214

EXPERIMENTAL

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID

Drug: TC-5214

Placebo

PLACEBO COMPARATOR

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID

Drug: Placebo

Interventions

TC-5214 DRUG

Twice daily for 8 weeks.

0.1 mg BID TC-5214; 1 mg BID TC-5214; 4 mg BID TC-5214

Placebo DRUG

Twice daily for 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.

Sponsors & Collaborators

• AstraZeneca: lead
• Targacept Inc.: collaborator

Study Sites (87)

Research Site

Buenos Aires, Buenos Aires F.D., Argentina

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Mendoza, Mendoza Province, Argentina

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Ciudad Autonoma Bs As, Cba, Argentina

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Dublin, Argentina

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Rio de Janeiro, Rio de Janeiro, Brazil

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Novi Iskar, Bulgaria

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Rousse, Bulgaria

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Santiago, Chile, Chile

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Antofagasta, Chile

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Providencia Santiago, Chile

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Bello, Antioquia, Colombia

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Bogota, Cundinamarca, Colombia

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Pereira, Risaralda Department, Colombia

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Cali, Valle del Cauca Department, Colombia

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Rijeka, Croatia

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Bully-les-Mines, France

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Caen, France

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Cherbourg, France

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Colmar, France

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Dole, France

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Douai, France

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Élancourt, France

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Montpellier, France

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Sartrouville, France

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Strasbourg, France

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Toulon, France

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Toulouse, France

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Tours, France

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Hüttenberg, Hesse, Germany

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Bad Homburg, Germany

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Bielefeld, Germany

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Gelsenkirchen, Germany

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Schwerin, Germany

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Siegen, Germany

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Balassagyarmat, Hungary

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Budapest, Hungary

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Győr, Hungary

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Bydgoszcz, Poland, Poland

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Bialystok, Poland

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Leszno, Poland

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Lublin, Poland

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Torun, Poland

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Arad, Romania

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Brasov, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Focşani, Romania

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Oradea, Romania

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Timișoara, Romania

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Arkhangelsk, Russia

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Chita, Russia

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Novosibirsk, Russia

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Petrozavodsk, Russia

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Saint Petersburg, Russia

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Tomsk, Russia

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Voronezh, Russia

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Yekaterinburg, Russia

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Kragujevac, Serbia and Montenegro, Serbia

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Niš, Serbia

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Banská Štiavnica, Slovakia

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Bratislava, Slovakia

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Levice, Slovakia

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Prešov, Slovakia

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Rimavská Sobota, Slovakia

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Svidník, Slovakia

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Trenčín, Slovakia

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Bloemfontein, Free State, South Africa

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Vereeniging, Free State, South Africa

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Cape Town, Western Cape, South Africa

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Centurion, South Africa

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Durban, South Africa

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George, South Africa

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Paarl, South Africa

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Port Elizabeth, South Africa

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Alcalá de Henares, Madrid, Spain

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Coslada, Madrid, Spain

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Langreo, Principality of Asturias, Spain

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Kharkiv, Ukraine, Ukraine

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Simferpool, Ukraine, Ukraine

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Vinnytsia, Ukraine, Ukraine

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Dnipropetrovsk, Ukraine

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Donetsk, Ukraine

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Kherson, Ukraine

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Kiev, Ukraine

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Lviv, Ukraine

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Poltava, Ukraine

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Ternopil, Ukraine

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Related Publications (1)

• Moller HJ, Demyttenaere K, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy. World J Biol Psychiatry. 2015 Oct;16(7):483-501. doi: 10.3109/15622975.2014.989261. Epub 2015 Jan 20.

  PMID: 25602163 DERIVED

Related Links

• CSR-D4130C00005.pdf
• D4130C00005/Clinical Study Protocol

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Hans A Eriksson, MD,PhD, MBA

  AstraZeneca R&D

  STUDY DIRECTOR

• Hans-Jürgen Möller, Prof. Dr.

  University Hospital München

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 9, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 11, 2014
• Results First Posted: October 29, 2012

Record last verified: 2014-03

Locations

DE (6); ES (3); RU (8); UA (10); SL (7); SE (2); BU (2); CL (3); CR (1); ZA (8); RO (7); BR (1); CO (4); HU (3); FR (13); PL (5); AR (4)