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

James Murrough

Status and phase

Completed

Phase 1

Conditions

Posttraumatic Stress Disorder

Treatments

Drug: Neuropeptide Y

Study type

Interventional

Funder types

Other

Identifiers

NCT01533519

GCO 11-1487

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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