Trial Outcomes & Findings for Monoamine Transporters Genotypes: Risk of PTSD and Related Comorbidities (NCT NCT00403455)
NCT ID: NCT00403455
Last Updated: 2018-07-02
Results Overview
The CAPS assessment is used to determine the severity of an individuals PTSD. The assessment examines Re-experiencing, Avoidance and Numbing, and Hyperarousal symptoms which total score in each of these categories are added together to achieve a total CAPS score. Scores on this assessment can range from 0-136 with 0 not having any PTSD symptoms and 136 having the most symptoms possible. The study uses this assessment at the baseline and at the end of treatment to determine the decrease in this score over the course of the study.
COMPLETED
PHASE3
38 participants
12 weeks
2018-07-02
Participant Flow
Participant milestones
| Measure |
Paroxetine Arm
This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
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|---|---|
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Overall Study
STARTED
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38
|
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Overall Study
COMPLETED
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37
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Paroxetine Arm
This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Monoamine Transporters Genotypes: Risk of PTSD and Related Comorbidities
Baseline characteristics by cohort
| Measure |
Paroxetine Arm
n=38 Participants
This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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31 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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7 Participants
n=99 Participants
|
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Age, Continuous
|
48.5789 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
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37 Participants
n=99 Participants
|
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Region of Enrollment
United States
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38 participants
n=99 Participants
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PRIMARY outcome
Timeframe: 12 weeksPopulation: All participants analyzed had a CAPS score of \>45 and were DSM-IV positive for PTSD. Both males and females with backgrounds in all ethnic groups were aloud to participate in the study.
The CAPS assessment is used to determine the severity of an individuals PTSD. The assessment examines Re-experiencing, Avoidance and Numbing, and Hyperarousal symptoms which total score in each of these categories are added together to achieve a total CAPS score. Scores on this assessment can range from 0-136 with 0 not having any PTSD symptoms and 136 having the most symptoms possible. The study uses this assessment at the baseline and at the end of treatment to determine the decrease in this score over the course of the study.
Outcome measures
| Measure |
Paroxetine Arm
n=36 Participants
This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
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|---|---|
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Clinician Administered PTSD Scale (CAPS)
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-21.72 Change in units on a scale
Interval -91.0 to 30.0
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Adverse Events
Paroxetine Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paroxetine Arm
n=38 participants at risk
This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
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|---|---|
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Gastrointestinal disorders
Minor Nausea
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28.9%
11/38 • All patients were monitored over a 12 weeks. During this time period no patients experienced any serious adverse events. A small number of participants experienced nausea and other minor symptoms which did not require them stopping the medication.
Paroxetine is and during the time of this study an open-label drug which is approved to treat PTSD. This study was conducted to analyze why some people respond to the medication better than others in relation to a persons genotype.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place