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Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
NCT01847469 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization will be done using 3:1 ratio and will be performed by our research pharmacy using a random assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo. Medication will be titrated over a 6 week titration phase followed by a 6 week treatment phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will be provided by trained and qualified clinicians with extensive experience providing E-CPT-C. Veterans will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Zonisamide
- BEHAVIORAL Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Study Locations (1)
Connecticut
- VA Connecticut Healthcare System — West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-06 |
| Est. Completion | 2019-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01847469
The ClinicalTrials.gov registry entry for NCT01847469 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 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 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 Alcohol Dependence appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT01847469 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. 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 NCT01847469 about?
NCT01847469 is a clinical study titled "Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence". This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization will be done using 3:1 rati...
What is the current status of trial NCT01847469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2013-06. Estimated completion is 2019-01-01.
What conditions does trial NCT01847469 study?
This clinical trial studies the following conditions: Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01847469?
The interventions under investigation include: Placebo (DRUG), Zonisamide (DRUG), Enhanced-Cognitive Processing Therapy-C (E-CPT-C) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01847469?
This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01847469 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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