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

Posttraumatic Stress Disorder Clinical Trial

Official title:

A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533519
• Other study ID #: GCO 11-1487
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2012
• Last updated: April 13, 2016
• Start date: December 2012
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Neuropeptide Y
Intranasal administration will be administered with a nasal drug delivery device.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
James Murrough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline and within 2 hours of administration of NPY	No
Secondary	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	baseline and within 2 hours of administration of NPY	No
Secondary	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	at baseline and within 2 hours of administration of NPY	No

External Links

•   Mood and Anxiety Disorders Program