Evaluation of a corticotropin releasing hormone type 1 receptor antagonist in women with posttraumatic stress disorder: study protocol for a randomized controlled trial

Table 1 Schedule of events

	Screening and pre-randomization assessment			Double-blind phase							Follow-up
Visit number	S1	V1	V2	V3	V4	V5	V6	V7	V8	V9	V10	V11
Week		−1	−1	0	1	2	4	5	5	6	7	10
Day		−7	−1	0	7	14	28	35	36	42	49	70
Informed consent	X
Demographics/Hollingshead	X
Vital signs	X	X	X	X	X	X	X	X	X	X	X	X
Weight	X			X			X			X	X	X
Physical examination	X									X
12-lead ECG	X		X				X			X
SCID-IV	X
Dispense study drug and diary				X	X	X	X
Screening laboratory tests	X
Fecal occult test		X
Safety laboratory testing			X	X	X	X	X			X
Pregnancy testing	X		X							X		X
Pharmacokinetics					X	X	X			X		X
Psychiatric measures
CAPS/MADRS/CSSRS/CGI	X			X	X	X	X			X	X	X
PSS-SR/QIDS-SR	X			X	X	X	X			X	X	X
CTQ and PDS screen	X
PSQI/BPI	X			X			X			X		X
SDS				X						X
LES				X						X
Safety measures
Adverse events/Concomitant medications	X	X	X	X	X	X	X	X	X	X	X	X
PRISE	X			X	X	X	X			X
FIBSER					X	X	X			X	X	X
Exploratory aims
Neuroendocrine measures			X	X				X	X
Startle testing		X						X
Neuropsychological testing		X						X
Genotype				X
mRNA			X					X

Abbreviations: BPI = Brief Pain Inventory; CAPS = Clinician-Administered PTSD Scale; CGI = Clinical Global Impression; CSSRS = Columbia Suicide Severity Rating Scale; CTQ = Childhood Trauma Questionnaire; ECG = electrocardiogram; FIBSER = Frequency, Intensity and Burden of Side Effects Rating; Hollingshead = Hollingshead 4 Factors of Social Status Scale; LES = Life Experiences Survey; MADRS = Montgomery-Asberg Depression Rating Scale; PDS = Posttraumatic Diagnostic Scale; PRISE = Patient Rated Inventory of Side Effects; PSQI = Pittsburgh Sleep Quality Index; PSS-SR = PTSD Symptom Scale Self Report; QIDS-SR = Quick Inventory of Depressive Symptoms; SCID = Structured Clinical Interview for DSM-IV; SDS = Sheehan Disability Scale.

ISSN: 1745-6215