Post Traumatic Stress Disorder (PTSD)Phase 2NCT00641511
Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)
A Phase 2 study testing SYN117 (nepicastat) in people with Post Traumatic Stress Disorder (PTSD), run by Michael E. DeBakey VA Medical Center at 3 sites in United States.
Trial summary
Assess the effect of nepicastat in the treatment of in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- SYN117 (nepicastat)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Nov 2009
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Patient understands the risks and benefits and agrees to visit frequency and procedures
- Male or female
- Any race or ethnic origin
- Served in conflict zones at least one time between 1990 -2008 [includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc]
- Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military
Show all 12Show fewer
- DSM-IV Diagnosis of Post-Traumatic Stress Disorder (PTSD)
- No substance use disorders (except for nicotine and caffeine) in the previous 2 months
- Free of psychotropic medication for 2 weeks prior to randomization (a low dose sedative hypnotic is allowed for severe insomnia if used sparingly)
- Physical and laboratory panel are within normal limits or not clinically significant
- Women of childbearing potential must be using medically-approved methods of birth control
- 18 to 65 years of age
Who cannot join
- Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders
- Actively considering plans of suicide or homicide
- Psychotic symptoms that in the investigator's opinion impair the patient's ability to give informed consent or make it unsafe for patient to be maintained without a neuroleptic
- Unstable general medical conditions or a contraindication to the use of nepicastat
- Intolerable side effects or allergic reaction to nepicastat
- Women planning to become pregnant or breastfeed during the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
Michael E. Debakey VAMC
Houston, Texas, 77030
Tuscaloosa VAMC
Tuscaloosa, Alabama, 35404
About this study
Official title: Pharmacogenetic Clinical Trial of Nepicastat for PTSD
Assess the effect of nepicastat in the treatment of in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo.
Read the detailed description
The primary treatment objective is to assess the global efficacy of nepicastat in the treatment of hyper-arousal in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo. The secondary treatment objectives are to assess the ability of nepicastat to induce PTSD remission; treat PTSD and other PTSD symptom clusters and improve quality of life and overall functioning. A medical safety objective is to assess the tolerability and side effects of nepicastat in the treatment of PTSD in veterans who served in conflict zones at least one time between 1990 -2008 [includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc .
This is a 6-week study with the long-term objective is to define the best approach to treating PTSD and enhancing the quality of life in patients. Results from this pilot study will assist clinicians in treating active military service members or veterans with PTSD by developing new treatment algorithms for future larger studies.
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Being tested
- SYN117 (nepicastat), Placebo comparator
- Keywords
- PTSD
- 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.
SYN117 (nepicastat)Drug
Also called nepicastat
120 mg per day
Placebo comparatorDrug
once per day placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| 1 (Medication arm - SYN117 aka Nepicastat) | Experimental | Veterans will be receiving the study medication Nepicastat initiated with a 3-day loading phase of 40 mg on day 1, 80 mg on day 2 and 120 mg on day 3 (orally) and be continued at 120 mg once daily; During the 8 weeks (weeks: 7-14) extension phase, those from both treatment groups of the RCT phase will start open-label, active Nepicastat (i.e. no chance of placebo) treatment and be followed for an additional 8 weeks. Those who have a prior defined positive clinical response to the study medication, Nepicastat, will be continued on open label Nepicastat at 120mg once daily, in order to assess further improvement and safety; those who do not have a positive clinical response during the 6 weeks RCT will be offered the addition of the standard first-line PTSD pharmacotherapy, Paroxetine. Paroxetine is an allowed concomitant medication (i.e. "rescue medication") and is not considered a research medication or subject of a research question during the 8 weeks extension phase. Receives: Drug: SYN117 (nepicastat) |
| 2 (Placebo arm) | Placebo comparator | During the 6 weeks ( weeks: 1-6) double- blind, randomized clinical trial (RCT) phase, the veterans who have been randomized to the placebo treatment group will be receiving placebo pills. During the 8 weeks (weeks: 7-14) extension phase, all veterans from both treatment groups of the RCT phase will start open-label, active Nepicastat (i.e. no chance of placebo) treatment and be followed by the study team for an additional 8 weeks. The veterans on the placebo during the RCT will receive the study medication at end of the study week 6, the medication will be initiated with a 3-day loading phase of 40 mg on day 1, 80 mg on day 2 and 120 mg on day 3 (orally) and be continued at 120 mg once daily for 8 weeks until the end of the study. Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in CAPS(D) hyperarousal scores as compared to placebo
Measured: 6 weeks
Secondary outcomes (7)
Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo
Measured: 6 weeeks
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo
Measured: 6 weeks
Clinicians global impression of Severity and Improvement
Measured: 6 weeks
Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Measured: 6 weeks
Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo
Measured: 6 weeks
Change from baseline in Sheehan Disability Scale as compared to placebo
Measured: 6 weeks
Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionNov 2009
Why it stopped: Houston site withdrew as a study site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Tuscaloosa Veterans Affairs Medical Center, Ralph H. Johnson VA Medical Center, Acorda Therapeutics
- Responsible party
- Principal investigator, Thomas Kosten, MD, Michael E. DeBakey VA Medical Center
- Investigators
- Thomas Kosten, MD, Study chair, Baylor College of Medicine, and DeBakey VAMCLori Davis, MD, Study director, Tuscaloosa VAMCMark Hamner, MD, Principal investigator, Ralph H Johnson VAMCDavid P. Graham, MD, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641511
- Sponsor's protocol ID
- H22601
- Other IDs
- Inv117-Kosten-CL01
- Status last verified
- Aug 2019
- First submitted
- 18 Mar 2008
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Clinical Trial of Nepicastat for PTSD
- ClinicalTrials.gov ID
- NCT00641511
- Acronym / sponsor ID
- H22601
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Keywords
- PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Houston site withdrew as a study site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- Tuscaloosa Veterans Affairs Medical Center, Ralph H. Johnson VA Medical Center, Acorda Therapeutics
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 24 Mar 2008 (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.
Assess the effect of nepicastat in the treatment of in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo.
Detailed description
The primary treatment objective is to assess the global efficacy of nepicastat in the treatment of hyper-arousal in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo. The secondary treatment objectives are to assess the ability of nepicastat to induce PTSD remission; treat PTSD and other PTSD symptom clusters and improve quality of life and overall functioning. A medical safety objective is to assess the tolerability and side effects of nepicastat in the treatment of PTSD in veterans who served in conflict zones at least one time between 1990 -2008 [includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc .
This is a 6-week study with the long-term objective is to define the best approach to treating PTSD and enhancing the quality of life in patients. Results from this pilot study will assist clinicians in treating active military service members or veterans with PTSD by developing new treatment algorithms for future larger studies.
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 (Medication arm - SYN117 aka Nepicastat) | Experimental | Drug: SYN117 (nepicastat)Veterans will be receiving the study medication Nepicastat initiated with a 3-day loading phase of 40 mg on day 1, 80 mg on day 2 and 120 mg on day 3 (orally) and be continued at 120 mg once daily; During the 8 weeks (weeks: 7-14) extension phase, those from both treatment groups of the RCT phase will start open-label, active Nepicastat (i.e. no chance of placebo) treatment and be followed for an additional 8 weeks. Those who have a prior defined positive clinical response to the study medication, Nepicastat, will be continued on open label Nepicastat at 120mg once daily, in order to assess further improvement and safety; those who do not have a positive clinical response during the 6 weeks RCT will be offered the addition of the standard first-line PTSD pharmacotherapy, Paroxetine. Paroxetine is an allowed concomitant medication (i.e. "rescue medication") and is not considered a research medication or subject of a research question during the 8 weeks extension phase. |
| 2 (Placebo arm) | Placebo comparator | Drug: Placebo comparatorDuring the 6 weeks ( weeks: 1-6) double- blind, randomized clinical trial (RCT) phase, the veterans who have been randomized to the placebo treatment group will be receiving placebo pills. During the 8 weeks (weeks: 7-14) extension phase, all veterans from both treatment groups of the RCT phase will start open-label, active Nepicastat (i.e. no chance of placebo) treatment and be followed by the study team for an additional 8 weeks. The veterans on the placebo during the RCT will receive the study medication at end of the study week 6, the medication will be initiated with a 3-day loading phase of 40 mg on day 1, 80 mg on day 2 and 120 mg on day 3 (orally) and be continued at 120 mg once daily for 8 weeks until the end of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent
- Patient understands the risks and benefits and agrees to visit frequency and procedures
- Male or female
- Any race or ethnic origin
- Served in conflict zones at least one time between 1990 -2008 [includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc]
Key exclusion criteria (6 listed)
- Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders
- Actively considering plans of suicide or homicide
- Psychotic symptoms that in the investigator's opinion impair the patient's ability to give informed consent or make it unsafe for patient to be maintained without a neuroleptic
- Unstable general medical conditions or a contraindication to the use of nepicastat
- Intolerable side effects or allergic reaction to nepicastat
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 |
|---|---|---|
| SYN117 (nepicastat)Also: nepicastat120 mg per day | Drug | 1 (Medication arm - SYN117 aka Nepicastat) |
| Placebo comparatoronce per day placebo capsules | Drug | 2 (Placebo arm) |
Primary outcome
Change from baseline in CAPS(D) hyperarousal scores as compared to placebo
Time frame: 6 weeks
7 secondary outcomes
Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo
Time frame: 6 weeeks
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo
Time frame: 6 weeks
Clinicians global impression of Severity and Improvement
Time frame: 6 weeks
Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Time frame: 6 weeks
Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo
Time frame: 6 weeks
Change from baseline in Sheehan Disability Scale as compared to placebo
Time frame: 6 weeks
Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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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.
Thomas Kosten, MD study chair
Baylor College of Medicine, and DeBakey VAMC
Lori Davis, MD study director
Tuscaloosa VAMC
Mark Hamner, MD principal investigator
Ralph H Johnson VAMC
3 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 SYN117 (nepicastat) in people with Post Traumatic Stress Disorder (PTSD), run by Michael E. DeBakey VA Medical Center at 3 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 12 inclusion and 6 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: withdrawn, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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 CAPS(D) hyperarousal scores as compared to placebo (time frame: 6 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 21 Aug 2019.