Post-Traumatic Stress DisorderNCT01066156
Post-Traumatic Stress Disorder (PTSD) and Seroquel
A study testing Seroquel in people with Post-Traumatic Stress Disorder, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Seroquel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Fluency in English
- A diagnosis of PTSD
- No pregnancy
- Right-handedness
Who cannot join
- 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
Show all 9Show fewer
- History of allergic reaction or hypersensitivity to Seroquel
- Contraindications to magnetic resonance imaging
- Treatment with an effective medication for PTSD
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Street Health Center
Somerville, Massachusetts, 02143
About this study
Official title: Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes
This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Seroquel
- Keywords
- Post-traumatic Stress Disorder, PTSD, Seroquel, fMRI
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeroquelDrug
Also called quetiapine
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
| Study group | Role | What they receive |
|---|---|---|
| Seroquel | Experimental | This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Receives: Drug: Seroquel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Elman, Cambridge Health Alliance
- Investigators
- Igor Elman, MD, Principal investigator, CHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066156
- Sponsor's protocol ID
- 2009-P-001664
- Status last verified
- Jun 2015
- First submitted
- 8 Feb 2010
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes
- ClinicalTrials.gov ID
- NCT01066156
- Acronym / sponsor ID
- 2009-P-001664
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Post-traumatic Stress Disorder, PTSD, Seroquel, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seroquel | Experimental | Drug: SeroquelThis study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written informed consent
- Fluency in English
- A diagnosis of PTSD
- No pregnancy
- Right-handedness
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeroquelAlso: quetiapineThis study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD | Drug | Seroquel |
Primary outcome
Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Elman, MD principal investigator
CHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seroquel in people with Post-Traumatic Stress Disorder, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.