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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH068173 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine | Experimental | Paroxetine and Prolonged Exposure Therapy |
|
| Placebo pill | Placebo Comparator | Placebo pill plus Prolonged Exposure Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug | Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD | Weeks 0,5,10 |
| Number of Participants Who Met Remission Criterion | remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1 | Weeks 5,10 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response at Weeks 5 and 10 | responder status: CGI-change score of 1 or 2 1=very much improved, 2= much improved | weeks 5,10 |
| Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin Schneier, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21908494 | Derived | Schneier FR, Neria Y, Pavlicova M, Hembree E, Suh EJ, Amsel L, Marshall RD. Combined prolonged exposure therapy and paroxetine for PTSD related to the World Trade Center attack: a randomized controlled trial. Am J Psychiatry. 2012 Jan;169(1):80-8. doi: 10.1176/appi.ajp.2011.11020321. Epub 2011 Sep 9. |
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Recruitment dates: December, 2004 to February, 2009. Location: Anxiety Disorders research clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paroxetine | Paroxetine and Prolonged Exposure Therapy |
| FG001 | Placebo Pill | Placebo pill plus Prolonged Exposure Therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Treatment |
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| |||||||||||||||||||||
| Maintenance Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paroxetine | Paroxetine and Prolonged Exposure Therapy |
| BG001 | Placebo Pill | Placebo pill plus Prolonged Exposure Therapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician Administered PTSD Scale (CAPS) | PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD | all participants who were randomized | Posted | Mean | Standard Deviation | units on a scale | Weeks 0,5,10 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paroxetine | Paroxetine and Prolonged Exposure Therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franklin Schneier MD | Research Foundation for Mental Hygiene | 212-543-5368 | frs1@columbia.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001521 | Behavior Therapy |
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| Prolonged Exposure Therapy | Behavioral | Weekly for 10 weeks |
|
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total score at weeks 0, 5, 10
| weeks 0,5,10 |
| Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10 | Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life | weeks 0,5,10 |
| Protocol Violation |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Treatment Response at Weeks 5 and 10 | responder status: CGI-change score of 1 or 2 1=very much improved, 2= much improved | all subjects randomized with dropouts carried forward as nonresponders | Posted | Number | participants | weeks 5,10 |
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|
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| Secondary | Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms | total score at weeks 0, 5, 10 | observed data at each time point | Posted | Mean | Standard Deviation | units on a scale | weeks 0,5,10 |
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|
|
| Secondary | Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10 | Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life | observed data at weeks 0, 5, and 10 | Posted | Mean | Standard Deviation | units on a scale | weeks 0,5,10 |
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|
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| Primary | Number of Participants Who Met Remission Criterion | remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1 | all participants who were randomized, with people who dropped out counted as non-remitters | Posted | Number | participants | Weeks 5,10 |
|
|
|
|
| 0 |
| 19 |
| 6 |
| 19 |
| EG001 | Placebo Pill | Placebo pill plus Prolonged Exposure Therapy | 0 | 18 | 5 | 18 |
| palpitations | Cardiac disorders | Systematic Assessment |
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| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| photophobia | Eye disorders | Systematic Assessment |
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| tachycardia | Cardiac disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| lightheadedness | Nervous system disorders | Systematic Assessment |
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| dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| blurry vision | Eye disorders | Systematic Assessment |
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| parasthesias | Nervous system disorders | Systematic Assessment |
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| decrease libido | Reproductive system and breast disorders | Systematic Assessment |
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| anorgasmia | Reproductive system and breast disorders | Systematic Assessment |
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| impaired coordination | Nervous system disorders | Systematic Assessment |
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| nervousness | Nervous system disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
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| insomnia | Nervous system disorders | Systematic Assessment |
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| weight gain | General disorders | Systematic Assessment |
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| weight loss | General disorders | Systematic Assessment |
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| skin problems | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| difficulty urinating | Renal and urinary disorders | Systematic Assessment |
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| rigidity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| somnolence | General disorders | Systematic Assessment |
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| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| week 10 |
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| week 10 |
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| Mixed Models Analysis |
| 0.007 |
| Odds Ratio (OR) |
| 20.8 |
| 2-Sided |
| 95 |
| 2.44 |
| 176 |
| No |
| Superiority or Other |