PTSDPhase 4PTSDNCT00237393
Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)
A Phase 4 study testing Quetiapine in people with PTSD, run by Ralph H. Johnson VA Medical Center at 2 sites in United States.
Trial summary
The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2003to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD.
- Score of at least 50 on the CAPS-SX at baseline.
- Competent to give informed consent.
- If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential.
- Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase.
- Other medications, if any, must have been kept stable for at least one month prior to randomization.
Who cannot join
- History of sensitivity to quetiapine
- Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period.
- Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease.
- Medical disorders that may cause or exacerbate anxiety symptoms.
- Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria.
- Schizophrenia, schizoaffective disorder, or bipolar disorder.
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- Suicidal or homicidal ideation or other clinically significant dangerousness
- Currently seeking compensation or increase in compensation for the effects of the trauma.
- Initiation or change in psychotherapy within 3 months of randomization.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NM VA Healthcare System
Albuquerque, New Mexico, 87108
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401
About this study
Official title: A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD
The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
Read the detailed description
Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms.
Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy.
Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.
- Conditions
- PTSD
- Being tested
- Quetiapine, Placebo
- Keywords
- PTSD, Posttraumatic stress disorder, Treatment, Quetiapine
- 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.
QuetiapineDrug
Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
PlaceboDrug
Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Quetiapine Receives: Drug: Quetiapine |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
Secondary outcomes (13)
Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
Hamilton Depression Rating Scale (HAMD)
Hamilton Rating Scale of Anxiety (HAMA)
Clinical Global Impression Severity Scale (CGI-S)
Clinical Global Impression Improvement Scale (CGI-I)
Davidson Trauma Scale (DTS)
Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
SDS
Arizona Sexual Experience Scale (ASEX)
AIMS
BAS
SAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startAug 2003
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ralph H. Johnson VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- AstraZeneca
- Investigators
- Mark B Hamner, MD, Principal investigator, Ralph H. Johnson VAMC/Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237393
- Sponsor's protocol ID
- 0058
- Other IDs
- HR-10762
- Acronym
- PTSD
- Status last verified
- Oct 2005
- First submitted
- 11 Oct 2005
- Last updated
- 21 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD
- ClinicalTrials.gov ID
- NCT00237393
- Acronym / sponsor ID
- PTSD / 0058
- Conditions
- PTSD
- Keywords
- PTSD, Posttraumatic stress disorder, Treatment, Quetiapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ralph H. Johnson VA Medical CenterUS federal agency
- Collaborators
- AstraZeneca
- Study start
- Aug 2003
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
Detailed description
Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms.
Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy.
Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: QuetiapineQuetiapine |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD.
- Score of at least 50 on the CAPS-SX at baseline.
- Competent to give informed consent.
- If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential.
- Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase.
Key exclusion criteria (9 listed)
- History of sensitivity to quetiapine
- Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period.
- Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease.
- Medical disorders that may cause or exacerbate anxiety symptoms.
- Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria.
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 |
|---|---|---|
| QuetiapineDosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS. | Drug | 1 |
| PlaceboDosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS. | Drug | 2 |
Primary outcome
Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
13 secondary outcomes
Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
Hamilton Depression Rating Scale (HAMD)
Hamilton Rating Scale of Anxiety (HAMA)
Clinical Global Impression Severity Scale (CGI-S)
Clinical Global Impression Improvement Scale (CGI-I)
Davidson Trauma Scale (DTS)
Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
SDS
Arizona Sexual Experience Scale (ASEX)
AIMS
BAS
SAS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2008.
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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.
Mark B Hamner, MD principal investigator
Ralph H. Johnson VAMC/Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine in people with PTSD, run by Ralph H. Johnson VA Medical Center at 2 sites 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 6 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 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12. 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 21 Feb 2008.