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NCT00692445 · ClinicalTrials.gov registry record · Phase 2
TC-5214 as add-on the Treatment of Major Depressive Disorder
A Phase 2 study of Depression and Major Depressive Disorder, sponsored by Targacept.
- Completed
- Registry status
- Phase 2
- Development phase
- 574
- Enrollment target
- 20
- Study locations
NCT00692445 is a Phase 2 study of Depression and Major Depressive Disorder that has completed, run by Targacept. The registered enrollment target is 574 participants, below the 785-participant average among 679 other Depression trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT00692445, a Phase 2 study of Depression and Major Depressive Disorder, has completed, sponsored by Targacept.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 574 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 574 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 785-participant average among 679 other Depression trials with a reported enrollment target (27% lower). The listed sponsor is Targacept, which has 13 total studies on file at ClinicalTrials.gov.
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.
NCT00692445 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Andhra Pradesh, Karnataka, Maharashtra.
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.
What interventions are being tested in trial NCT00692445?
The interventions under investigation include: TC-5214 + citalopram (DRUG), Placebo + citalopram (DRUG).
Who is sponsoring clinical trial NCT00692445?
This trial is sponsored by Targacept, which has 13 total clinical trials registered on ClinicalTrials.gov.
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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.