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TC-5214 as add-on the Treatment of Major Depressive Disorder

Information source: Targacept Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Depression

Intervention: TC-5214 + citalopram (Drug); Placebo + citalopram (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Targacept Inc.

Official(s) and/or principal investigator(s):
Alfredo N Rivera, MD, Principal Investigator, Affiliation: Community Research

Summary

This is a multi-center, double blind, randomized, placebo-controlled, parallel group, flexible dose titration study conducted in centers in the USA and India. Following a washout period, subject will be treated with citalopram 20 mg once daily for 4 weeks, then with 40 mg once daily for 4 weeks. Subjects who tolerate 40 mg citalopram, but whose MADRS score is < 50% from baseline, but no lower than 17, will be considered partial or non-responders and will be randomized to receive either placebo or TC-5214 as add-on therapy. TC-5214 or placebo will be started at 2 mg daily (BID dosing), and be titrated based on tolerability and therapeutic response up to 8 mg daily. Approximately 560 subjects will enter the Open Label Phase and approximately 220 will enter the double blind phase of the study.

Clinical Details

Official title: A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of TC-5214 in the Treatment of MDD With Subjects Who Are Partial Responders or Non-Responders to Citalopram Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean change between TC-5214 and placebo from DB baseline (Week 8) of the HAMD-17 score, at Week 16.

Secondary outcome: Number of Participants with Adverse Events

Detailed description: This is a multi-center, double blind, randomized, placebo-controlled, parallel group, flexible dose titration study conducted in centers in the USA and India. Following a washout period, subject will be treated with citalopram 20 mg once daily for 4 weeks, then with 40 mg once daily for 4 weeks. Subjects who tolerate 40 mg citalopram, but whose MADRS score is reduced 50% from baseline, but no lower than 17, will be considered partial or non-responders and will be randomized to receive either placebo or TC-5214 as Add:-on therapy. TC-5214 or placebo will be started at 2 mg daily (1mg BID dosing). After 2 weeks treatment, medication can be increased to 4 mg (2mg BID) or continued unchanged. Dose escalation will depend on good tolerability and inadequate therapeutic response. After a further 2 weeks, medication can be increased to 8 mg (4mg BID) if felt appropriate by the investigator. Again, dose escalation will depend on good tolerability and inadequate therapeutic response. At any time during the double blind phase of the study, placebo or TC-5214 can be reduced to the last previous dose level following the emergence of unacceptable adverse event(s). If a subject is prematurely discontinued from the study between Week 8 and Week 16 for any reason, the investigator will make every effort to perform all evaluations as per protocol, assuming the subject had reached the end of the double blind Add:-on treatment phase. These evaluations are to be made as soon as possible but within 2 weeks of discontinuation. For the subjects completing the double blind phase of the study, there will be a follow-up visit 2-3 weeks after the last dose of trial medication. At this follow-up, any signs or symptoms of relapse will be evaluated.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Diagnosis of major depressive disorder (MDD) according to DSM-IV and confirmed via MINI diagnostic scale 2. No more than 1 prior antidepressant course of treatment before trial entry. 3. Able to give written informed consent. 4. MADRS score greater than 27. 5. CGI-S score greater than or equal to 4. 6. No clinically significant abnormality on physical examination, vital signs, ECG or laboratory tests at screening. 7. Women of child bearing potential must: a) have a negative urine pregnancy test, b) not be nursing, and c) be willing to use acceptable methods of contraception throughout the study period. Exclusion Criteria: 1. Any co morbid psychiatric illness confirmed by MINI diagnostic scale, especially bipolar disorder, schizophrenia, dementia, or PTSD 2. Subjects with significant suicidal risk upon clinical assessment utilizing the M. I.N. I. 3. History of alcohol or drug abuse over the last 6 months 4. History of seizures or seizure disorders 5. Any other severe progressive and uncontrolled medical condition 6. For other controlled medical conditions, medication to be unchanged over the 2 months preceding screening, or else the subject will be excluded 7. Subjects with Glaucoma, Kidney Disease or Heart Disease 8. Known hypersensitivity to mecamylamine 9. Other investigational drug in previous 30 days 10. Screening QTcB or QTcF > 450 msec 11. Current or prior citalopram treatment

Locations and Contacts

Sravani Poly Clinic and Mental Health, Guntur, Andhra Pradesh Guntur-522001, India

Asha Hospital, Hyderabaad, Andhra Pradesh 500034, India

Brain Mind Behaviour Neuroscience Research Institute, Maharanipet, Andhra Pradesh 530002, India

VIMHANS, Vijaywada, Andhra Pradesh 520002, India

Government Hospital for Mental Care, Dept. of Psychiatry, Visakhapatnam, Andhra Pradesh 530017, India

SV Medical College, Tirupati, Chittoor District, Andhra Pradesh 517507, India

AIIMS, New Dehli, Dehli 110029, India

GB pant Hospital, Indraprastha, Delhi 110002, India

Bhora Nuro Psychiatric Centre, New Delhi, Delhi 110065, India

Aurora Clinical Trials, Miami, Florida 33143, United States

Sri Kishna Prasad Psychiatric Nursing Home, Ahmedabad, Gujarat 380006, India

St. John's Hospital, Bangalore, Karnataka 560034, India

Victoria Hospital, Dept. of Psychiatry, Bangalore, Karnataka 560002, India

Adhit Kiran Neuro Psychiatric Centre, Mangalore, Karnataka 572002, India

JSS Medical College Hospital, Dept. of Psychiatry, Mysore, Karnataka 570004, India

Bhopal Memorial Hospital & Research Centre, Dept. of Psychiatry, Bhopal, Madhya Pradesh 462038, India

Holy Family Hospital, Mumbai, Maharashtra 400050, India

Deenanath Maneshkas Hospital, Pune, Maharashtra 411 004, India

Poona Hospital & Research Centre, Pune, Maharashtra 411030, India

Sanjeevan Hospital, Pune, Maharashtra 411004, India

Community Research, Cincinnati, Ohio 45227, United States

Gautam Hospital & Research Center, Jaipur, Rajasthan 302006, India

Madras Medical College, Chennai, Tamilnadu 600003, India

M.S. Chellamuthu Trust & Research Foundation, Madurai, Tamilnadu 625 020, India

UT Southwestern Medical Center, Dallas, Texas 75390, United States

Mahendru Psychiatric Centre, Kanpur, Uttar Pradesh 208005, India

C.S.M. Medical University, Department of Psychiatry, Lucknow, Uttar Pradesh 226003, India

Additional Information

Starting date: June 2008
Last updated: June 13, 2013

Page last updated: August 23, 2015

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