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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH056120 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study was to assess the effects of the medication paroxetine on symptoms of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD symptoms accompanied by changes in brain functional response to reminders of childhood trauma.
The main purpose of this study was to look at the effects of paroxetine on PTSD symptoms and brain function in women with posttraumatic stress disorder (PTSD) related to childhood abuse. Participants underwent baseline assessment with of PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and brain function during exposure to traumatic scripts of childhood abuse. Participants then were treated in a randomized double-blind fashion with paroxetine or placebo for three months, followed by a repeat of these assessments.
Specific Aims of this proposal were therefore to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine Group | Experimental | Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months. |
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| Placebo Group | Placebo Comparator | Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months. |
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| PTSD Negative | Other | Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments. They do not undergo intervention therefore they are assessed at baseline only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score | The CAPS is a 30-item questionnaire of PTSD symptomatology that provides continuous measures of symptom severity and frequency. CAPS-IV total symptom severity score is calculated by summing severity scores for the 17 DSM-IV PTSD symptoms. Each symptom is rated for severity based on frequency and intensity on a scale of 0-4 for a total possible severity score per symptom of 8. Criterion E (items 18-19) is duration of symptoms (minimum of one month to make the diagnosis). Items 20-30 are optional. CAPS score is based on items 1-17, CAPS score has a potential range of 0-136, with higher scores indicating greater severity of PTSD symptoms. CAPS was performed before and after treatment with paroxetine or placebo in PTSD patients. | Baseline, End of Study (Up to 52 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM) | Participants were exposed to traumatic scripts versus neutral scripts before and after treatment with paroxetine or placebo. Brain blood flow was measured using statistical parametric mapping (SPM) which analyzes brain imaging data sequences. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group. Data for each participant can not be generated using this software and therefore are not available to summarize in the data table below. Regional blood flow was compared for stress and neutral conditions and before and after treatment with paroxetine or placebo. Higher z-scores indicate an increase in regional blood flow to the medial prefrontal cortex under stress conditions for the 3 month time point relative to baseline. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James D. Bremner, MD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30306 | United States |
Of the 91 participants who were consented, 7 were excluded due to not meeting screening criteria.
Participants were recruited from the Emory Clinic and Emory University Hospitals from September 2006 to November 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paroxetine Group | Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months. Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
| FG001 | Placebo Group | Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months. Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
| FG002 | PTSD Negative | Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paroxetine Group | Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months. Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
| 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 | Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score | The CAPS is a 30-item questionnaire of PTSD symptomatology that provides continuous measures of symptom severity and frequency. CAPS-IV total symptom severity score is calculated by summing severity scores for the 17 DSM-IV PTSD symptoms. Each symptom is rated for severity based on frequency and intensity on a scale of 0-4 for a total possible severity score per symptom of 8. Criterion E (items 18-19) is duration of symptoms (minimum of one month to make the diagnosis). Items 20-30 are optional. CAPS score is based on items 1-17, CAPS score has a potential range of 0-136, with higher scores indicating greater severity of PTSD symptoms. CAPS was performed before and after treatment with paroxetine or placebo in PTSD patients. | Data for participants who completed all study visits were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of Study (Up to 52 Weeks) |
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Adverse events were collected for the duration of the study and open label period (2 years). Adverse events were collected for all participants who began the study.
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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 Group | Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months. Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Douglas Bremner | Emory University | 404-712-9569 | doug.bremner@emory.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013057 | Spectrum Analysis |
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| Paroxetine | Drug | Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. |
|
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| Positron Emission Tomography (PET) Imaging | Other | Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts |
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| Baseline, 3 Months Post Treatment |
| Lost to Follow-up |
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| BG001 | Placebo Group | Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months. Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
| BG002 | PTSD Negative | Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
| BG003 | 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 |
|
Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months. Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
| OG001 | Placebo Group | Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months. Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. |
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| Secondary | Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM) | Participants were exposed to traumatic scripts versus neutral scripts before and after treatment with paroxetine or placebo. Brain blood flow was measured using statistical parametric mapping (SPM) which analyzes brain imaging data sequences. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group. Data for each participant can not be generated using this software and therefore are not available to summarize in the data table below. Regional blood flow was compared for stress and neutral conditions and before and after treatment with paroxetine or placebo. Higher z-scores indicate an increase in regional blood flow to the medial prefrontal cortex under stress conditions for the 3 month time point relative to baseline. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group. | Statistical analyses yielded image data sets in which the values assigned to individual voxels correspond to the t-statistic of the difference in brain blood flow between conditions. Statistical images were displayed with values of z score units. | Posted | Number | z-scores | Baseline, 3 Months Post Treatment |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo Group | Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months. Placebo: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months. Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | PTSD Negative | Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks. | 0 | 56 | 0 | 56 | 0 | 56 |
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |