Stress Disorders, Post-TraumaticPhase 2NCT01018992
Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder
A Phase 2 study testing GSK561679 in people with Stress Disorders, Post-Traumatic, run by Emory University at 4 sites in United States.
Trial summary
This study will test the hypothesis of whether an antagonist at the corticotropin releasing factor type 1 (CRF1) receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- GSK561679
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2009to Aug 2014
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female between 21-65 years of age
- Able to provide consent and willing to participate in research
- Fulfills Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for primary diagnosis of PTSD
- PTSD duration of illness at least 3 months
- Able to provide consent and willing to participate in research
- CAPS score of ≥ 50 at Screening and Visit 3 (randomization)
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- Negative Urine toxicology test
- Agrees to use protocol-defined effective birth control method
- If the patient has a history of peptic ulcer disease (PUD), there is documentation of the etiology of the PUD and that effective treatment was provided with full eradication of ulcers and symptoms
Who cannot join
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder, obsessive compulsive disorder (OCD), or current Axis I disorder [(except for major depression secondary to the PTSD, dysthymia, depression not otherwise specified (NOS) and anxiety disorders (panic disorder, social phobia, generalized anxiety disorder (GAD), specific phobia)]
- Subject is currently participating in another clinical trial in which she is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to PTSD, or 1 month for studies related to PTSD
- Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, central nervous system (CNS) tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of GSK561679.
- Patients who in the investigator's judgment pose a current suicidal or homicidal risk
- DSM-IV substance abuse or dependence within the past 90 days. Subject has a positive test for illegal substances.
- Diagnosis of anorexia nervosa or bulimia in the past year.
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- Subject has a documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody), and/or clinically significant hepatic enzyme elevation including any one of the following enzymes greater than 1.5 times the upper limit of normal (ULN) value (alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total or direct bilirubin > 1.5 x ULN, unless consistent with presumed or diagnosed Gilbert's disease)
- Subject has taken systemic corticosteroids within 2 weeks of the Randomization Visit
- Treatment with any other psychoactive medication within 2 weeks of Visit 1, including all antidepressants, psychoactive herbal or nutritional treatment (St Johns Wort, SAM-e), lithium, other mood stabilizers, oral antipsychotics, depot antipsychotics within 12 weeks, beta blockers, thioridazine, pimozide, opiates, anxiolytics, and sedatives (with the exception of zolpidem, eszopiclone, and zaleplon). Also any treatment with any medication that the PI judges not acceptable for this study.
- Subject who is likely to require the use of the following medications: Chronic (for more than 2 weeks), regular nonsteroidal anti-inflammatory drugs (NSAID) use. Any use of aspirin (including low dose)
- Subject has taken non-psychoactive (prescription or non-prescription), dietary, or herbal products, with a narrow therapeutic index, that are metabolized via the cytochrome P450 3A4 or 2C9 pathway (warfarin), or transported via OATP1B1 or P-gp, within 2 weeks (or 5 half-lives, whichever is longer) prior to the Randomization Visit.
- Subject has taken other (non-psychoactive) prescription, non-prescription, dietary, or herbal products that are potent inducers or inhibitors of the cytochrome P450 3A4 pathway for 2 weeks (or 5 half lives, whichever is longer) prior to the Randomization Visit.
- Subject has a stool positive for occult blood.
- Pregnancy or lactation
- Subjects who, in the opinion of the investigator, would be non compliant with the visit schedule or study procedures (e.g. illiteracy, planned vacations, or planned hospitalizations during the study).
- Previous treatment with CRF1 receptor antagonist
- Any laboratory abnormality that in the investigator's judgment is considered to be clinically significant (blood pressure, electrocardiogram (ECG), thyroid stimulating hormone (TSH), liver function test (LFT), etc.)
- Patients who are receiving exposure-based psychotherapy that targets PTSD symptoms
- Current or planned litigation or other actions related to secondary gain regarding the traumatic event
- Subject has clinical evidence of, or ECG results indicating any of the following at either screen or Randomization Visit unless repeat ECG shows that the parameter had returned to within normal range by the Randomization Visit:
- Corrected QT Interval (QTc) > 450 msec;
- any cardiac condition or ECG evidence that the investigator feels may predispose the subject to ischemia or arrhythmia; or
- any ECG abnormality that, in the investigator's judgment, may pose a potential safety concern
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30306
Baylor College of Medicine
Houston, Texas, 77030
Mount Sinai School of Medicine
New York, New York, 10029
Stress and Health Research Program, San Francisco VA Medical Center, University of California San Francisco
San Francisco, California, 94121
About this study
Official title: Evaluation of the Efficacy of the CRF1 Antagonist GSK561679 in Women With Post-traumatic Stress Disorder
This study will test the hypothesis of whether an antagonist at the corticotropin releasing factor type 1 (CRF1) receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of post-traumatic stress disorder (PTSD).
Read the detailed description
Post-traumatic stress disorder (PTSD) is a chronic and common anxiety disorder that follows exposure to an overwhelming traumatic event. The majority of patients with PTSD also meet criteria for other psychiatric disorders and PTSD is associated with an increased risk for suicide attempts.
PTSD is responsive to psychological and pharmacological treatments, such as selective serotonin reuptake inhibitors (SSRIs), but response rates rarely exceed 60%, and even fewer patients (20-30%) achieve clinical remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD.
The study is divided into 4 phases:
Phase 1 (Screening): a 1 week no drug screening period to assess study eligibility.
Phase 2 (Pre-Treatment Testing Period): Eligible patients will be enrolled into a 1 week Testing Phase, which will include neuropsychological and neurophysiological testing as well as blood draws and electrocardiogram.
Phase 3 (Treatment Period): Eligible patients will be enrolled in a two-armed 6-week period of double-blind placebo-controlled acute treatment. All subjects who continue to meet eligibility criteria will be randomized to one of two groups: GSK561679 (at a fixed dose of 350 mg/day) or placebo. Randomization will be performed at a 1:1 ratio into two treatment groups. Neuropsychological and neurophysiological testing will be repeated after 5 weeks of the double-blind treatment period.
Phase 4 (Follow-up Period): Safety follow-up visits will be conducted 1 week and 1 month after the end of the treatment Phase 3.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- GSK561679, Placebo
- Keywords
- PTSD, Anxiety Disorder, Corticotropin releasing factor, Women
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK561679Drug
Also called CRF1 antagonist
GSK561679, oral administration, 350mg/day, 6 week administration
PlaceboDrug
Also called Sugar Pill
Matching placebo, oral administration, 1 pill/day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Adult women with DSM-IV defined PTSD will receive matching placebo for 6 weeks Receives: Drug: Placebo |
| GSK561679 | Experimental | Adult women with DSM-IV-defined PTSD will receive GSK561679 at a fixed dose of 350 mg/day for 6-weeks Receives: Drug: GSK561679 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score
The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.
Measured: Baseline, Week 6
Secondary outcomes (3)
Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline
The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured has having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).
Measured: Baseline, Week 6
Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.
Measured: Baseline, Week 6
Safety, Measured by the Number of Subjects That Experienced an Adverse Event
The occurrence of adverse events will be recorded at the end of 6 weeks.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2014
- Study completionAug 2014
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Boadie W. Dunlop, Emory University
- Investigators
- Boadie Dunlop, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018992
- Sponsor's protocol ID
- IRB00022717
- Other IDs
- MH069056
- Status last verified
- Jan 2017
- First submitted
- 6 Nov 2009
- Last updated
- 7 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jovanovic T, Duncan EJ, Kaye J, Garza K, Norrholm SD, Inslicht SS, Neylan TC, Mathew SJ, Iosifescu D, Rothbaum BO, Mayberg HS, Dunlop BW. Psychophysiological treatment outcomes: Corticotropin-releasing factor type 1 receptor antagonist increases inhibition of fear-potentiated startle in PTSD patients. Psychophysiology. 2020 Jan;57(1):e13356. doi: 10.1111/psyp.13356. Epub 2019 Feb 26.
PubMed 30807663Pape JC, Carrillo-Roa T, Rothbaum BO, Nemeroff CB, Czamara D, Zannas AS, Iosifescu D, Mathew SJ, Neylan TC, Mayberg HS, Dunlop BW, Binder EB. DNA methylation levels are associated with CRF1 receptor antagonist treatment outcome in women with post-traumatic stress disorder. Clin Epigenetics. 2018 Nov 3;10(1):136. doi: 10.1186/s13148-018-0569-x.
PubMed 30390684Dunlop BW, Rothbaum BO, Binder EB, Duncan E, Harvey PD, Jovanovic T, Kelley ME, Kinkead B, Kutner M, Iosifescu DV, Mathew SJ, Neylan TC, Kilts CD, Nemeroff CB, Mayberg HS. Evaluation of a corticotropin releasing hormone type 1 receptor antagonist in women with posttraumatic stress disorder: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:240. doi: 10.1186/1745-6215-15-240.
PubMed 24950747
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the CRF1 Antagonist GSK561679 in Women With Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01018992
- Acronym / sponsor ID
- IRB00022717
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Anxiety Disorder, Corticotropin releasing factor, Women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Dec 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 30 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the hypothesis of whether an antagonist at the corticotropin releasing factor type 1 (CRF1) receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of post-traumatic stress disorder (PTSD).
Detailed description
Post-traumatic stress disorder (PTSD) is a chronic and common anxiety disorder that follows exposure to an overwhelming traumatic event. The majority of patients with PTSD also meet criteria for other psychiatric disorders and PTSD is associated with an increased risk for suicide attempts.
PTSD is responsive to psychological and pharmacological treatments, such as selective serotonin reuptake inhibitors (SSRIs), but response rates rarely exceed 60%, and even fewer patients (20-30%) achieve clinical remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD.
The study is divided into 4 phases:
Phase 1 (Screening): a 1 week no drug screening period to assess study eligibility.
Phase 2 (Pre-Treatment Testing Period): Eligible patients will be enrolled into a 1 week Testing Phase, which will include neuropsychological and neurophysiological testing as well as blood draws and electrocardiogram.
Phase 3 (Treatment Period): Eligible patients will be enrolled in a two-armed 6-week period of double-blind placebo-controlled acute treatment. All subjects who continue to meet eligibility criteria will be randomized to one of two groups: GSK561679 (at a fixed dose of 350 mg/day) or placebo. Randomization will be performed at a 1:1 ratio into two treatment groups. Neuropsychological and neurophysiological testing will be repeated after 5 weeks of the double-blind treatment period.
Phase 4 (Follow-up Period): Safety follow-up visits will be conducted 1 week and 1 month after the end of the treatment Phase 3.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAdult women with DSM-IV defined PTSD will receive matching placebo for 6 weeks |
| GSK561679 | Experimental | Drug: GSK561679Adult women with DSM-IV-defined PTSD will receive GSK561679 at a fixed dose of 350 mg/day for 6-weeks |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female between 21-65 years of age
- Able to provide consent and willing to participate in research
- Fulfills Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for primary diagnosis of PTSD
- PTSD duration of illness at least 3 months
- Able to provide consent and willing to participate in research
Key exclusion criteria (23 listed)
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder, obsessive compulsive disorder (OCD), or current Axis I disorder [(except for major depression secondary to the PTSD, dysthymia, depression not otherwise specified (NOS) and anxiety disorders (panic disorder, social phobia, generalized anxiety disorder (GAD), specific phobia)]
- Subject is currently participating in another clinical trial in which she is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to PTSD, or 1 month for studies related to PTSD
- Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, central nervous system (CNS) tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of GSK561679.
- Patients who in the investigator's judgment pose a current suicidal or homicidal risk
- DSM-IV substance abuse or dependence within the past 90 days. Subject has a positive test for illegal substances.
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 |
|---|---|---|
| GSK561679Also: CRF1 antagonistGSK561679, oral administration, 350mg/day, 6 week administration | Drug | GSK561679 |
| PlaceboAlso: Sugar PillMatching placebo, oral administration, 1 pill/day for 6 weeks | Drug | Placebo |
Primary outcome
Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score
Time frame: Baseline, Week 6
The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.
3 secondary outcomes
Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline
Time frame: Baseline, Week 6
Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time frame: Baseline, Week 6
Safety, Measured by the Number of Subjects That Experienced an Adverse Event
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30807663Jovanovic T, Duncan EJ, Kaye J, Garza K, Norrholm SD, Inslicht SS, Neylan TC, Mathew SJ, Iosifescu D, Rothbaum BO, Mayberg HS, Dunlop BW. Psychophysiological treatment outcomes: Corticotropin-releasing factor type 1 receptor antagonist increases inhibition of fear-potentiated startle in PTSD patients. Psychophysiology. 2020 Jan;57(1):e13356. doi: 10.1111/psyp.13356. Epub 2019 Feb 26.
- Derived from this study: PubMed 30390684Pape JC, Carrillo-Roa T, Rothbaum BO, Nemeroff CB, Czamara D, Zannas AS, Iosifescu D, Mathew SJ, Neylan TC, Mayberg HS, Dunlop BW, Binder EB. DNA methylation levels are associated with CRF1 receptor antagonist treatment outcome in women with post-traumatic stress disorder. Clin Epigenetics. 2018 Nov 3;10(1):136. doi: 10.1186/s13148-018-0569-x.
- Derived from this study: PubMed 24950747Dunlop BW, Rothbaum BO, Binder EB, Duncan E, Harvey PD, Jovanovic T, Kelley ME, Kinkead B, Kutner M, Iosifescu DV, Mathew SJ, Neylan TC, Kilts CD, Nemeroff CB, Mayberg HS. Evaluation of a corticotropin releasing hormone type 1 receptor antagonist in women with posttraumatic stress disorder: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:240. doi: 10.1186/1745-6215-15-240.
- Emory Mood and Anxiety Disorders Program WebsiteLink provided by the sponsor.
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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.
Boadie Dunlop, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK561679 in people with Stress Disorders, Post-Traumatic, run by Emory University at 4 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 9 inclusion and 23 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 30 Jul 2015). 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?
Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score (time frame: Baseline, Week 6). 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 NCT01018992, which also lists 3 linked publications.
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 Mar 2017.