A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)

NCT ID: NCT01533519

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-01-31

Brief 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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

NPY/placebo

This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY.

Group Type: EXPERIMENTAL

Neuropeptide Y

Intervention Type: DRUG

Intranasal administration will be administered with a nasal drug delivery device.

placebo/NPY

This arm gets placebo (saline) first then NPY.

Group Type: EXPERIMENTAL

Neuropeptide Y

Intervention Type: DRUG

Intranasal administration will be administered with a nasal drug delivery device.

Interventions

Neuropeptide Y

Intranasal administration will be administered with a nasal drug delivery device.

Intervention Type: DRUG

Other Intervention Names

NPY

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Murrough

OTHER

Sponsor Role: lead

Responsible Party

James Murrough

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James Murrough, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29186416 (View on PubMed)

Other Identifiers

GCO 11-1487

Identifier Type: -

Identifier Source: org_study_id