Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
TC-5214 as add-on the Treatment of Major Depressive Disorder
NCT00692445 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG TC-5214 + citalopram
- DRUG Placebo + citalopram
Study Locations (20)
Andhra Pradesh
- Sravani Poly Clinic and Mental Health — Guntur
- Asha Hospital — Hyderabaad
- Brain Mind Behaviour Neuroscience Research Institute — Maharanipet
- VIMHANS — Vijaywada
- Government Hospital for Mental Care, Dept. of Psychiatry — Visakhapatnam
Karnataka
- Victoria Hospital, Dept. of Psychiatry — Bangalore
- St. John's Hospital — Bangalore
- Adhit Kiran Neuro Psychiatric Centre — Mangalore
- JSS Medical College Hospital, Dept. of Psychiatry — Mysore
Maharashtra
- Holy Family Hospital — Mumbai
- Deenanath Maneshkas Hospital — Pune
- Sanjeevan Hospital — Pune
- Poona Hospital & Research Centre — Pune
Florida
- Aurora Clinical Trials — Miami
Ohio
- Community Research — Cincinnati
Texas
- UT Southwestern Medical Center — Dallas
Chittoor District, Andhra Pradesh
- SV Medical College — Tirupati
Dehli
- AIIMS — New Dehli
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 574 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00692445
The ClinicalTrials.gov registry entry for NCT00692445 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 574 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Targacept, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions — of which TC-5214 + citalopram is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00692445 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Andhra Pradesh, Karnataka, Maharashtra. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00692445 about?
NCT00692445 is a clinical study titled "TC-5214 as add-on the Treatment of Major Depressive Disorder". 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. Sub...
What is the current status of trial NCT00692445?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 574 participants. The study started on 2008-06. Estimated completion is 2009-07.
What conditions does trial NCT00692445 study?
This clinical trial studies the following conditions: Depression, Major Depressive Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00692445?
The interventions under investigation include: TC-5214 + citalopram (DRUG), Placebo + citalopram (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00692445?
This trial is sponsored by Targacept, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00692445 being conducted?
This trial has 20 study locations across Florida, Ohio, Texas, Andhra Pradesh, Chittoor District, Andhra Pradesh. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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