Posttraumatic Stress DisorderPhase 1NCT01533519
A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)
A Phase 1 study testing Neuropeptide Y in people with Posttraumatic Stress Disorder, run by James Murrough at 1 site in United States.
Trial summary
This study is designed to investigate the safety of intranasal administration of NPY using a dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Neuropeptide Y
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2016
- Phase
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women, age 18-60.
- Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document. We determine whether they have a sufficient understanding of the study procedures and risks by asking them to explain what's involved in the study and to give examples of study risks and benefits.
- Participants must fulfill DSM-IV criteria for current PTSD, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the Clinician-Administered PTSD Scale (CAPS).
- CAPS score must be at least 40 (moderate PTSD severity) at screening.
Who cannot join
- Current, primary Axis I disorders other than PTSD.
- History or current bipolar disorder or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder).
- Current diagnosis of anorexia nervosa or bulimia nervosa.
- Women who are pregnant or are breast-feeding.
- Drug or alcohol abuse or dependence within the preceding 3 months.
- poorly controlled hypertension (manifest by SBP > 140 and/or DBP > 90); HR < 60 or > 100 at rest at the time of screening and confirmed immediately prior to randomization
Show all 16Show fewer
- Evidence of coronary artery disease as evidenced by history, abnormal ECG, typical symptoms
- History of arrhythmia, cardiac surgery, or family history of sudden death
- Hepatic dysfunction as defined by AST and ALT > 2x URL, or alkaline phosphatase and bilirubin > 1.5 x URL within X days prior to randomization
- Chronic renal disease as defined by serum creatinine > 1.9
- Any other serious or unstable clinically significant abnormal findings of laboratory parameters, physical examination, or ECG as determined by the PI.
- Any other serious or unstable condition that would put the subjects at undue risk as determined by the PI or additional safety monitor.
- Serious and imminent suicidal or homicidal risk.
- Psychotropic medication that will not be tapered off at least 7 days prior to screening; withdrawal symptoms must be absent at the time of screening
- History of nasal disorders or sinonasal surgery, or significant nasal abnormalities based on nasal exam.
- Received investigational intervention within 30 days prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD
This study is designed to investigate the safety of intranasal administration of NPY using a dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Neuropeptide Y
- Keywords
- Neuropeptide Y, Intranasal Administration, PTSD, Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropeptide YDrug
Also called NPY
Intranasal administration will be administered with a nasal drug delivery device.
| Study group | Role | What they receive |
|---|---|---|
| NPY/placebo | Experimental | This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY. Receives: Drug: Neuropeptide Y |
| placebo/NPY | Experimental | This arm gets placebo (saline) first then NPY. Receives: Drug: Neuropeptide Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Inventory of Side Effects (PRISE)
Clinician-administered and safety measures will take place right before and after the administration to identify and evaluate the tolerability of each possible symptom (from baseline to within 2 hours of NPY administration).
Measured: baseline and within 2 hours of administration of NPY
Secondary outcomes (2)
State-Trait Anxiety Inventory (STAI)
Self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic effects of intranasal administration of NPY
Measured: baseline and within 2 hours of administration of NPY
Change in Beck Anxiety Inventory (BAI)
Self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic effects of intranasal administration of NPY
Measured: at baseline and within 2 hours of administration of NPY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2016
- Study completionJan 2016
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 Posttraumatic Stress DisorderStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Murrough
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, James Murrough, Icahn School of Medicine at Mount Sinai
- Investigators
- James Murrough, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533519
- Sponsor's protocol ID
- GCO 11-1487
- Status last verified
- Apr 2016
- First submitted
- 31 Jan 2012
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sayed S, Van Dam NT, Horn SR, Kautz MM, Parides M, Costi S, Collins KA, Iacoviello B, Iosifescu DV, Mathe AA, Southwick SM, Feder A, Charney DS, Murrough JW. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. Int J Neuropsychopharmacol. 2018 Jan 1;21(1):3-11. doi: 10.1093/ijnp/pyx109.
PubMed 29186416
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD
- ClinicalTrials.gov ID
- NCT01533519
- Acronym / sponsor ID
- GCO 11-1487
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Neuropeptide Y, Intranasal Administration, PTSD, Trauma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- James MurroughUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Feb 2012 (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.
This study is designed to investigate the safety of intranasal administration of NPY using a dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPY/placebo | Experimental | Drug: Neuropeptide YThis arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY. |
| placebo/NPY | Experimental | Drug: Neuropeptide YThis arm gets placebo (saline) first then NPY. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women, age 18-60.
- Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document. We determine whether they have a sufficient understanding of the study procedures and risks by asking them to explain what's involved in the study and to give examples of study risks and benefits.
- Participants must fulfill DSM-IV criteria for current PTSD, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the Clinician-Administered PTSD Scale (CAPS).
- CAPS score must be at least 40 (moderate PTSD severity) at screening.
Key exclusion criteria (16 listed)
- Current, primary Axis I disorders other than PTSD.
- History or current bipolar disorder or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder).
- Current diagnosis of anorexia nervosa or bulimia nervosa.
- Women who are pregnant or are breast-feeding.
- Drug or alcohol abuse or dependence within the preceding 3 months.
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 |
|---|---|---|
| Neuropeptide YAlso: NPYIntranasal administration will be administered with a nasal drug delivery device. | Drug | NPY/placebo, placebo/NPY |
Primary outcome
Patient Rated Inventory of Side Effects (PRISE)
Time frame: baseline and within 2 hours of administration of NPY
Clinician-administered and safety measures will take place right before and after the administration to identify and evaluate the tolerability of each possible symptom (from baseline to within 2 hours of NPY administration).
2 secondary outcomes
State-Trait Anxiety Inventory (STAI)
Time frame: baseline and within 2 hours of administration of NPY
Change in Beck Anxiety Inventory (BAI)
Time frame: at baseline and within 2 hours of administration of NPY
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 14 Apr 2016.
- Derived from this study: PubMed 29186416Sayed S, Van Dam NT, Horn SR, Kautz MM, Parides M, Costi S, Collins KA, Iacoviello B, Iosifescu DV, Mathe AA, Southwick SM, Feder A, Charney DS, Murrough JW. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. Int J Neuropsychopharmacol. 2018 Jan 1;21(1):3-11. doi: 10.1093/ijnp/pyx109.
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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.
James Murrough, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neuropeptide Y in people with Posttraumatic Stress Disorder, run by James Murrough 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 4 inclusion and 16 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 14 Apr 2016. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Patient Rated Inventory of Side Effects (PRISE) (time frame: baseline and within 2 hours of administration of NPY). 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 NCT01533519, 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 14 Apr 2016.