Post-Traumatic Stress DisorderPhase 2NCT05103657
A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
A Phase 2 study testing BI 1358894 in people with Post-Traumatic Stress Disorder, run by Boehringer Ingelheim at 61 sites in 8 countries.
Trial summary
This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder. Participants are put into 2 groups randomly, which means by chance. 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?
- BI 1358894
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 61 sitesin 8 countries
- Study dates
- 7 Dec 2021to 20 Nov 2023
- Phase
- Phase 2
- 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
- Established diagnosis of Post-Traumatic Stress Disorder (PTSD) corresponding to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
- Time since index event according to Life Events Checklist / Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Criterion A at least 3 months before screening visit
- PTSD must be the clinically pre-dominant disorder, as per investigator´s judgement. Other comorbid psychiatric disorders are allowed, unless specifically excluded in the exclusion criteria
- A total severity score of ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5) at the screening visit
- Moderate to severe PTSD confirmed by CAPS-5 range ≥ 30 confirmed at screening visit
- Male or female patients, 18 to 65 years of age, both inclusively at the time of informed consent
- Women who are of child-bearing potential (WOCBP) must be able and willing to use two methods of contraception, as confirmed by the investigator, which include one highly effective method of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1%, plus one additional barrier method
- Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Who cannot join
- Corresponding to DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder, brief psychotic disorder or any other psychotic disorder as well as Major Depressive Disorder (MDD) with psychotic features as assessed by the Mini-International Neuropsychiatric Interview (MINI) at the time of screening
- Any psychiatric or non-psychiatric medical condition likely to negatively impact trial participation as per the judgement of the investigator
- Acute stress disorder or significant traumatic event within 3 months prior to the screening visit
- Use of stimulant medications within 3 months prior to the screening visit (Attention Deficit Hyperactivity Disorder (ADHD) diagnosis alone is not exclusionary)
- Severe traumatic brain injury (life-time) or moderate traumatic brain injury within the last 2 years prior to screening visit or 3 months for mild traumatic brain injury, based on the Ohio State University Traumatic Brain Injury (TBI) Identification Method Short Form. Or history of traumatic brain injury that would impact ability to complete trial assessments or procedures according to investigator.
- Current treatment with trauma focused therapy (i.e. Cognitive Processing Therapy (CPT), Prolonged Exposure Therapy (PE), Eye Movement Desensitization and Reprocessing (EMDR)). A psychotherapy in type, intensity and/or frequency other than trauma focused therapy is allowed if stable within the last 8 weeks prior to screening and not anticipated to change during the entire course of the trial. Long-term psychotherapy is permitted as long as patients are not in an exposure phase during the trial.
- Diagnosis of a current moderate or severe alcohol use disorder according to MINI within 3 months prior to screening visit (mild alcohol use disorder (AUD) and patients in early remission = criterion not met for between 3 \& 12 months are allowed) Further exclusion criteria apply
Trial locations and contacts
61 sites in 8 countries.
61 sites in 8 countries
United States37 sites
Institute for Advanced Medical Research
Alpharetta, Georgia, 30022
Emory University
Atlanta, Georgia, 30329
The University of Texas at Austin
Austin, Texas, 78712
Pharmasite Research, Incorporated
Baltimore, Maryland, 21208
Insight Clinical Trials
Beachwood, Ohio, 44122
Hassman Research Institute
Berlin, New Jersey, 08009
NeuroBehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
Boston Clinical Trials
Boston, Massachusetts, 02131
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Center For Emotional Fitness
Cherry Hill, New Jersey, 08002
American Medical Research
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
CNS Clinical Research - Coral Springs
Coral Springs, Florida, 33067
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Relaro Medical Trials, LLC
Dallas, Texas, 75243
Mountain Mind. LLC
Denver, Colorado, 80202
Behavioral Research Specialists, LLC
Glendale, California, 91206
Baylor College of Medicine
Houston, Texas, 77030
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Innovative Clinical Research
Lauderhill, Florida, 33319
Woodland International Research Group, Inc.
Little Rock, Arkansas, 72211
ASCLEPES Research Centers, P.C. dba Alliance Research
Long Beach, California, 90807
CalNeuro Research Group Inc.
Los Angeles, California, 90025
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Medical Research Group of Central Florida
Orange City, Florida, 32763
Princeton Medical Institute
Princeton, New Jersey, 08540
Artemis Institute for Clinical Research
Riverside, California, 92503
Salem VA Medical Center
Salem, Virginia, 24153
Audie L. Murphy VA Hospital
San Antonio, Texas, 78229
Artemis Institute for Clinical Research, LLC
San Diego, California, 92103
Clinical Innovations Inc.
Santa Ana, California, 92705
California Neuroscience Research
Sherman Oaks, California, 91403
Sisu BHR, LLC
Springfield, Massachusetts, 01103
Elixia PHC, LLC
St. Petersburg, Florida, 33713
Collaborative Neuroscience Research, LLC
Torrance, California, 90504
Grayline Research Center
Wichita Falls, Texas, 76309
Croatia5 sites
Clincal Hospital Centre Rijeka
Rijeka, 51 000
Polyclinic Neuron
Zagreb, 10000
Solmed Polyclinic
Zagreb, 10000
Psychiatric Hospital 'Sveti Ivan'
Zagreb, 10090
University Psychiatric Hospital Vrapce
Zagreb, 10090
Germany4 sites
Universitätsklinikum Aachen, AöR
Aachen, 52074
Zentralinstitut für seelische Gesundheit
Mannheim, 68159
Klinikum der Universität München - Campus Innenstadt
München, 80336
Universitätsklinikum Tübingen
Tübingen, 72076
Mexico4 sites
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
Culiacán, 80230
Hospital Aranda de la Parra
León, 37000
CIT-Neuropsique S.C
Monterrey, 64610
BIND Investigaciones S.C.
San Luis Potosí City, 78213
Sweden4 sites
Psykiatri Södra Stockholm
Enskede, 122 31
Psykiatri Affektiva sjukdomar
Gothenburg, 416 50
Psykiatri Sydväst Stockholm
Huddinge/Stockholm, 141 86
Akademiska sjukhuset
Uppsala, 751 85
Finland3 sites
Eira Medical Centre
Helsinki, 00150
Oulu Mentalcare Oy
Oulu, 90100
Mehiläinen Tampere
Tampere, FI-33210
Poland3 sites
MlynowaMed
Bialystok, 15-404
In-Vivo Sp. Z o.o.
Bydgoszcz, 85-048
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
About this study
Official title: A Phase II, 8-week-treatment, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy, Tolerability and Safety of Orally Administered BI 1358894 in Patients With Post-Traumatic Stress Disorder (PTSD)
This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder.
Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine.
Read more
Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change.
The doctors also regularly check participants' health and take note of any unwanted effects.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- BI 1358894, Placebo
- 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.
BI 1358894Drug
BI 1358894
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 1358894 125 mg | Experimental | Not described Receives: Drug: BI 1358894 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8
CAPS-5 is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Least Squares (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.
Measured: The MMRM model is a longitudinal analysis and it incorporated CAPS-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported.
Secondary outcomes (3)
CAPS-5 Response, Defined as ≥30% CAPS-5 Reduction From Baseline at Week 8
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity.
Number of participants with ≥30% CAPS-5 reduction from baseline at Week 8 is reported.
Measured: At baseline and at 8 weeks after start of treatment.
CAPS-5 Response, Defined as ≥50% CAPS-5 Reduction From Baseline at Week 8
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity.
Number of participants with ≥50% CAPS-5 reduction from baseline at Week 8 is reported.
Measured: At baseline and at 8 weeks after start of treatment.
Change From Baseline on the PTSD Checklist for DSM-5 (PCL-5) Total Score at Week 8
The PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) is a 20-item patient-reported assessment designed to measure the presence and severity of PTSD symptoms in the past month. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Each item is rated on a five point Likert scale, from 0 (not at all) to 4 (extremely) yielding a total score from 0-80 with higher scores indicating higher severity of the symptoms.
Least Square (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.
Measured: The MMRM model is a longitudinal analysis and it incorporated PCL-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start7 Dec 2021
- Primary completion12 Oct 2023
- Study completion20 Nov 2023
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.
- More trials run by Boehringer IngelheimThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103657
- Sponsor's protocol ID
- 1402-0030
- Other IDs
- 2021-003154-23
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2021
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, 8-week-treatment, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy, Tolerability and Safety of Orally Administered BI 1358894 in Patients With Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT05103657
- Acronym / sponsor ID
- 1402-0030
- Conditions
- Post-Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder.
Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine.
Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change.
The doctors also regularly check participants' health and take note of any unwanted effects.
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 |
|---|---|---|
| BI 1358894 125 mg | Experimental | Drug: BI 1358894 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Established diagnosis of Post-Traumatic Stress Disorder (PTSD) corresponding to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
- Time since index event according to Life Events Checklist / Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Criterion A at least 3 months before screening visit
- PTSD must be the clinically pre-dominant disorder, as per investigator´s judgement. Other comorbid psychiatric disorders are allowed, unless specifically excluded in the exclusion criteria
- A total severity score of ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5) at the screening visit
- Moderate to severe PTSD confirmed by CAPS-5 range ≥ 30 confirmed at screening visit
Key exclusion criteria (7 listed)
- Corresponding to DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder, brief psychotic disorder or any other psychotic disorder as well as Major Depressive Disorder (MDD) with psychotic features as assessed by the Mini-International Neuropsychiatric Interview (MINI) at the time of screening
- Any psychiatric or non-psychiatric medical condition likely to negatively impact trial participation as per the judgement of the investigator
- Acute stress disorder or significant traumatic event within 3 months prior to the screening visit
- Use of stimulant medications within 3 months prior to the screening visit (Attention Deficit Hyperactivity Disorder (ADHD) diagnosis alone is not exclusionary)
- Severe traumatic brain injury (life-time) or moderate traumatic brain injury within the last 2 years prior to screening visit or 3 months for mild traumatic brain injury, based on the Ohio State University Traumatic Brain Injury (TBI) Identification Method Short Form. Or history of traumatic brain injury that would impact ability to complete trial assessments or procedures according to investigator.
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 |
|---|---|---|
| BI 1358894BI 1358894 | Drug | BI 1358894 125 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change From Baseline in Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8
Time frame: The MMRM model is a longitudinal analysis and it incorporated CAPS-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported.
CAPS-5 is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Least Squares (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.
3 secondary outcomes
CAPS-5 Response, Defined as ≥30% CAPS-5 Reduction From Baseline at Week 8
Time frame: At baseline and at 8 weeks after start of treatment.
CAPS-5 Response, Defined as ≥50% CAPS-5 Reduction From Baseline at Week 8
Time frame: At baseline and at 8 weeks after start of treatment.
Change From Baseline on the PTSD Checklist for DSM-5 (PCL-5) Total Score at Week 8
Time frame: The MMRM model is a longitudinal analysis and it incorporated PCL-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
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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.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1358894 in people with Post-Traumatic Stress Disorder, run by Boehringer Ingelheim at 61 sites in 8 countries.
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 8 inclusion and 7 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Croatia, Germany, Mexico, Sweden and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). 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 Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8 (time frame: The MMRM model is a longitudinal analysis and it incorporated CAPS-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported.). 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 7 Nov 2024.