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Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)

Primary Purpose

Post Traumatic Stress Disorder (PTSD)

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SYN117 (nepicastat)
Placebo comparator
Sponsored by
Michael E. DeBakey VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder (PTSD) focused on measuring PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent
  2. Patient understands the risks and benefits and agrees to visit frequency and procedures
  3. Male or female
  4. Any race or ethnic origin
  5. Served in conflict zones at least one time between 1990 -2008 [includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc]
  6. Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military
  7. DSM-IV Diagnosis of Post-Traumatic Stress Disorder (PTSD)
  8. No substance use disorders (except for nicotine and caffeine) in the previous 2 months
  9. Free of psychotropic medication for 2 weeks prior to randomization (a low dose sedative hypnotic is allowed for severe insomnia if used sparingly)
  10. Physical and laboratory panel are within normal limits or not clinically significant
  11. Women of childbearing potential must be using medically-approved methods of birth control
  12. 18 to 65 years of age

Exclusion Criteria:

  1. Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders
  2. Actively considering plans of suicide or homicide
  3. 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
  4. Unstable general medical conditions or a contraindication to the use of nepicastat
  5. Intolerable side effects or allergic reaction to nepicastat
  6. Women planning to become pregnant or breastfeed during the study

Sites / Locations

  • Tuscaloosa VAMC
  • Ralph H. Johnson VA Medical Center
  • Michael E. Debakey VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1 (Medication arm - SYN117 aka Nepicastat)

2 (Placebo arm)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in CAPS(D) hyperarousal scores as compared to placebo

Secondary Outcome Measures

Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo
Clinicians global impression of Severity and Improvement
Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo
Change from baseline in Sheehan Disability Scale as compared to placebo
Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo

Full Information

First Posted
March 18, 2008
Last Updated
August 19, 2019
Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
Tuscaloosa Veterans Affairs Medical Center, Ralph H. Johnson VA Medical Center, Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00641511
Brief Title
Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)
Official Title
Pharmacogenetic Clinical Trial of Nepicastat for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Houston site withdrew as a study site.
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
Tuscaloosa Veterans Affairs Medical Center, Ralph H. Johnson VA Medical Center, Acorda Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder (PTSD)
Keywords
PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 (Medication arm - SYN117 aka Nepicastat)
Arm Type
Experimental
Arm Description
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.
Arm Title
2 (Placebo arm)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SYN117 (nepicastat)
Other Intervention Name(s)
nepicastat
Intervention Description
120 mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
once per day placebo capsules
Primary Outcome Measure Information:
Title
Change from baseline in CAPS(D) hyperarousal scores as compared to placebo
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo
Time Frame
6 weeeks
Title
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo
Time Frame
6 weeks
Title
Clinicians global impression of Severity and Improvement
Time Frame
6 weeks
Title
Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Time Frame
6 weeks
Title
Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo
Time Frame
6 weeks
Title
Change from baseline in Sheehan Disability Scale as compared to placebo
Time Frame
6 weeks
Title
Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kosten, MD
Organizational Affiliation
Baylor College of Medicine, and DeBakey VAMC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lori Davis, MD
Organizational Affiliation
Tuscaloosa VAMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark Hamner, MD
Organizational Affiliation
Ralph H Johnson VAMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David P. Graham, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuscaloosa VAMC
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Michael E. Debakey VAMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)

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