The purpose of this study is to see whether ketamine, when given repeatedly via the nose (intranasally), can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD.
The objective of the present research protocol, a parallel-arm, double-blind, randomized controlled clinical trial, is to test the efficacy of repeated intranasal administration of the glutamatergic NMDA receptor antagonist ketamine in providing (1) rapid relief of and (2) sustained improvement in core PTSD symptoms and co-morbid depressive symptoms in patients with chronic PTSD. The effects of ketamine will be compared with those of repeated intranasal administration of the benzodiazepine anesthetic midazolam, which mimics some of the acute subjective effects of ketamine but is expected to have lesser or less sustained anxiolytic effect, and no sustained antidepressant effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Impact of Events Scale-Revised (IES-R)
The IES-R is used to self-report measures of stress reactions to traumatic events. It measures both intrusion and avoidance.
Time frame: 24 hours
Clinician Administered PTSD Scale (CAPS)
The CAPS is a structured clinical interview designed to assess the essential features of PTSD.
Time frame: up to 4 weeks
Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)
The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days.
Time frame: 24 hours
Montgomery Asberg Depression Rating Scale (MADRS)
The MADRS is a 10-item instrument used for the evaluation of depressive symptoms and for the assessment of any changes to those symptoms.
Time frame: 24 hours
Patient-Rated Inventory of Side Effects (PRISE)
PRISE is a 7-item self report used to qualify side effects by identifying and evaluating the tolerability of each symptoms.
Time frame: 24 hours
Sheehan Disability Scale (SDS)
The SDS is a 10 point visual analog scale developed to assess functional impairment.
Time frame: 24 hours
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