A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)
Completed · Phase 1 · Has a placebo group
Conditions studied: Posttraumatic Stress Disorder
In brief
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.
Key facts
- Study ID
- NCT01533519
- Run by
- James Murrough
- People needed
- 26
- Starts
- 2012-12-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-04-14
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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