Post Traumatic Stress DisorderEarly Phase 1NCT04280965
Quetiapine Augmentation of PE Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury
A Early Phase 1 study testing Quetiapine Fumarate in people with Post Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
A pilot study to evaluate feasibility for a full-scale merit application. Specifically, for veterans considering prolonged exposure (PE) therapy, following the model established by Foa et al, we need to establish safety, and feasibility of quetiapine compared to treatment as usual (TAU) which employs multiple… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Quetiapine Fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 17 Oct 2022
- Phase
- Early Phase 1
- 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
- All treatment seeking adult (≥ 18 years)
- Veterans with mTBI who meet PTSD diagnosis and have a CAPS-5 score of 25 or greater. Diagnosis will be determined using the provisional PTSD diagnosis convention recommended by the National Center of PTSD which requires at least moderate ratings (2 or more) on at least 1 B item (items #1-5), 1 C item (items #6-7), 2 D items (#8-14), and 2 E items (items #15-20) of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
- Exclusion Criteria: (1) Pregnant or lactating women and those of child-bearing potential not using a reliable method of contraception; (2) Individuals meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or neurocognitive disorder; (3) Individuals currently taking any typical or atypical antipsychotic medication or individuals using daily benzodiazepines including nonbenzodiazepine z-drugs for sleep as they have effects similar to benzodiazepines for sleep. (Note: benzodiazepine use is contraindicated as they may impair learning required for progress with PE) (4) Individuals with known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal or endocrinological condition, diabetes mellitus, and/or seizure disorder. (5) Individuals with substance use disorder severe enough to require medical detoxification.
- Individuals who report suicidal or homicidal ideations in the past month severe enough to warrant inpatient admission.
- Individuals with current or known history of cardiac arrhythmia or QTc interval ≥ 450 milliseconds. (Note) Patients requiring other anti-arousal medication for general medical conditions such as antihypertensive medications, beta blockers etc., for hypertension, anti-thyroid medications for hyperthyroidism, and/or anti-epileptic medications, divalproex, levetiracetam, or carbamazepine for seizure disorder may be included if stable for at least 1 month before the screening visit.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quetiapine Augmentation of Prolonged Exposure (PE) Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury
A pilot study to evaluate feasibility for a full-scale merit application. Specifically, for veterans considering prolonged exposure (PE) therapy, following the model established by Foa et al, we need to establish safety, and feasibility of quetiapine compared to treatment as usual (TAU) which employs multiple medications commonly used for PTSD in the VA system.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Quetiapine Fumarate, Standard of care meducations
- 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.
Quetiapine FumarateDrug
Also called Seroquel
Atypical antipsychotic
Standard of care meducationsOther
SSRI's/SNRI's/Trazodone/Prazosin/Hydroxyzine
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | Flexible dosing begins at 50 mg, titrating up to 100 mg at the end of week 2 with additional doses up to 400 mg per day if needed Receives: Drug: Quetiapine Fumarate |
| Treatment As Usual (TAU) | Active comparator | Standard of care medications Receives: Other: Standard of care meducations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage compliance in completing PE sessions
The percentage of participants who complete the 10 sessions of Prolonged Exposure (PE) within 12-14 weeks of beginning treatment.
Measured: 1.5 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Feb 2019
- Primary completion29 Apr 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- South Central MIRECC
- Responsible party
- Sponsor
- Investigators
- Muhammad Baig, MD, Principal investigator, South Texas Veterans Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280965
- Sponsor's protocol ID
- 18-200H
- Status last verified
- May 2023
- First submitted
- 19 Feb 2020
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD that underlie results in publication
Publications
Baig MR, Beck RD, Wilson JL, Lemmer JA, Meraj A, Meyer EC, Mintz J, Peterson AL, Roache JD. Quetiapine augmentation of prolonged exposure therapy in veterans with PTSD and a history of mild traumatic brain injury: design and methodology of a pilot study. Mil Med Res. 2020 Oct 8;7(1):46. doi: 10.1186/s40779-020-00278-0.
PubMed 33032657
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine Augmentation of Prolonged Exposure (PE) Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04280965
- Acronym / sponsor ID
- 18-200H
- Conditions
- Post Traumatic Stress Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- South Central MIRECC
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 21 Feb 2020 (actual)
- 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.
A pilot study to evaluate feasibility for a full-scale merit application. Specifically, for veterans considering prolonged exposure (PE) therapy, following the model established by Foa et al, we need to establish safety, and feasibility of quetiapine compared to treatment as usual (TAU) which employs multiple medications commonly used for PTSD in the VA system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: Quetiapine FumarateFlexible dosing begins at 50 mg, titrating up to 100 mg at the end of week 2 with additional doses up to 400 mg per day if needed |
| Treatment As Usual (TAU) | Active comparator | Other: Standard of care meducationsStandard of care medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All treatment seeking adult (≥ 18 years)
- Veterans with mTBI who meet PTSD diagnosis and have a CAPS-5 score of 25 or greater. Diagnosis will be determined using the provisional PTSD diagnosis convention recommended by the National Center of PTSD which requires at least moderate ratings (2 or more) on at least 1 B item (items #1-5), 1 C item (items #6-7), 2 D items (#8-14), and 2 E items (items #15-20) of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
- Exclusion Criteria: (1) Pregnant or lactating women and those of child-bearing potential not using a reliable method of contraception; (2) Individuals meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or neurocognitive disorder; (3) Individuals currently taking any typical or atypical antipsychotic medication or individuals using daily benzodiazepines including nonbenzodiazepine z-drugs for sleep as they have effects similar to benzodiazepines for sleep. (Note: benzodiazepine use is contraindicated as they may impair learning required for progress with PE) (4) Individuals with known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal or endocrinological condition, diabetes mellitus, and/or seizure disorder. (5) Individuals with substance use disorder severe enough to require medical detoxification.
- Individuals who report suicidal or homicidal ideations in the past month severe enough to warrant inpatient admission.
- Individuals with current or known history of cardiac arrhythmia or QTc interval ≥ 450 milliseconds. (Note) Patients requiring other anti-arousal medication for general medical conditions such as antihypertensive medications, beta blockers etc., for hypertension, anti-thyroid medications for hyperthyroidism, and/or anti-epileptic medications, divalproex, levetiracetam, or carbamazepine for seizure disorder may be included if stable for at least 1 month before the screening visit.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Quetiapine FumarateAlso: SeroquelAtypical antipsychotic | Drug | Quetiapine |
| Standard of care meducationsSSRI's/SNRI's/Trazodone/Prazosin/Hydroxyzine | Other | Treatment As Usual (TAU) |
Primary outcome
Percentage compliance in completing PE sessions
Time frame: 1.5 yr
The percentage of participants who complete the 10 sessions of Prolonged Exposure (PE) within 12-14 weeks of beginning treatment.
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 9 May 2023.
- Derived from this study: PubMed 33032657Baig MR, Beck RD, Wilson JL, Lemmer JA, Meraj A, Meyer EC, Mintz J, Peterson AL, Roache JD. Quetiapine augmentation of prolonged exposure therapy in veterans with PTSD and a history of mild traumatic brain injury: design and methodology of a pilot study. Mil Med Res. 2020 Oct 8;7(1):46. doi: 10.1186/s40779-020-00278-0.
- Individual participant dataSharing planned: Yes. All de-identified IPD that underlie results in publication
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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.
Muhammad Baig, MD principal investigator
South Texas Veterans Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Quetiapine Fumarate in people with Post Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio 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 0 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 9 May 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Percentage compliance in completing PE sessions (time frame: 1.5 yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04280965, which also lists 1 linked publication.
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 9 May 2023.