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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this study is to determine whether vilazodone is effective in the treatmen of Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (Viibryd) | Experimental | 10 mg/day 1 to 7; 20 mg/day 8 to 14; 40 mg/day week 3 to end week 12. Subjects will then be tapered off vilazodone as follows: 20 mg/day week 13, 10 mg/day, week 14 and no medication during week 15. |
|
| Placebo | Placebo Comparator | will be compared to the treatment group (viibryd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment (Viibryd) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PTSD symptoms | PCL-C | four months |
| PTSD Diagnosis | CAPS | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | BDI-II | four months |
| Sleep | PSQI | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | serum | four months |
Inclusion Criteria:
Exclusion Criteria:
Patients with a concurrent DSM-IV Axis I diagnosis in any of the following categories:
Decisional incapacity (dementia)
Use of centrally acting medications that potentially have an effect on biological expression
Chronic pain levels requiring use of any opiate medications
Known exposure to chemicals of physical traumas that cause neuropsychiatric sequelae
Past chronic PTSD
History of 2 or more treatment failures on SSRIs given primarily for the treatment of PTSD, in adequate does at the Investigator's opinion, for at least 8 weeks
History of intolerance or hypersensitivity to SSRI's
History of seizures
Significant risk of committing suicide, or are homicidal or violent and in the Investigator's opinion in significant imminent risk of hurting others
Treated with depot-neuroleptic within 3 months or MAO inhibitors within 30 day prior to Baseline visit
Received ECT within 3 months prior to Screening visit
Pregnant or nursing, women of childbearing potential who are sexually active and do not use adequate contraception, or who are judged to be unreliable in their use of contraception
Positive urine drug screen, unless proven to be prescribed for a short-term course of treatment. Drug screen must be repeated at least 7 days after the last dose of prescription medication containing narcotics
A medical condition, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial
Requiring concomitant treatment with any psychotropic drug (except zolpidem for sleep)
Plans to initiate or terminate any form of psychotherapy or behavior therapy during the study
Receiving disability payments (> 50 % service connections or total Social Security) or who are involved in litigation for PTSD or other psychiatric illnesses.
Unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Long Beach Healthcare System | Long Beach | California | 90822 | United States | ||
| Veterans Affairs Nebraska Western-Iowa Healthcare Systems |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28858440 | Derived | Ramaswamy S, Driscoll D, Reist C, Smith LM, Albers LJ, Rose J, Nguyen L, Monga V, Doria R, Hollifield M. A Double-Blind, Placebo-Controlled Randomized Trial of Vilazodone in the Treatment of Posttraumatic Stress Disorder and Comorbid Depression. Prim Care Companion CNS Disord. 2017 Aug 24;19(4):17m02138. doi: 10.4088/PCC.17m02138. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000069503 | Vilazodone Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
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| Anxiety |
HSCL-25 |
| 4 months |
| Omaha |
| Nebraska |
| 68105 |
| United States |
| D001519 | Behavior |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |