Post-Traumatic Stress Disorder
Conditions
Keywords
Post-traumatic Stress Disorder, PTSD, Seroquel, fMRI
Brief summary
This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.
Detailed description
An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. If no obvious counterindications are present, subjects will be scheduled for a screening visit. After briefing the subjects on the reasons for the research, they will be given an opportunity to read the Informed Consent Form, approved by the Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.
Interventions
DRUGSeroquel
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Sponsors
Cambridge Health Alliance
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent * Fluency in English * A diagnosis of PTSD * No pregnancy * Right-handedness
Exclusion criteria
* Pregnancy or lactation * Any cognitive impairment that precludes informed consent * Known intolerance or lack of response to Seroquel * Previous enrollment or randomization of treatment in the present study * Participation in another drug trial within 4 weeks prior enrollment into this study * Patients with Diabetes Mellitus * History of allergic reaction or hypersensitivity to Seroquel * Contraindications to magnetic resonance imaging * Treatment with an effective medication for PTSD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint. | 8 weeks | We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Seroquel This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ineligible | 2 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Seroquel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 51.3 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment United States | 34 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.
We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed
Time frame: 8 weeks
Population: It was predicted that patients will show a change in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seroquel | Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint. | 7.3 units on a scale | Standard Deviation 18.5 |