NCT01221792.

Study name	Carvedilol versus placebo for treatment in post traumatic stress disorder (PTSD)
Methods	Study type: Interventional Study phase: Phase 2 Allocation: Randomized Intervention model: Parallel assignment Masking: quadruple (participant, care provider, investigator, outcomes assessor) Primary purpose: Treatment
Participants	Inclusion criteria: Diagnosis of Post Traumatic Stress Disorder according to DSM‐IV; must be able to speak, read and understand the English language and be able to provide written informed consent Exclusion criteria: Current, unstable and significant medical condition/illness; bronchial asthma or related bronchospastic condition; AV block; Sick Sinus Syndrome; Bradycardia; Peripheral hear disease; Unstable thyroid disorder; History of seizure disorder; Women who are pregnant, lactating or planning to become pregnant; bipolar; schizophrenia; dementia; intolerance or hypersensitivity to alpha or beta blockers
Interventions	Drug: Carvedilol: oral, twice‐daily dosing using 3.125 mg tablets.1 week titration (6.25 mg/day) prior to a 3‐week flexible dosing option ranging from 6.25 mg/day to 15.625 mg/day followed by a 1 week taper (6.25 mg/day) Other name: Coreg® Drug: Placebo Non‐active comparator
Outcomes	Primary outcome mMeasures: Davidson Trauma Scale (DTS) ( Time frame: 5 weeks). The DTS is a 17‐item self report measure to assess the 17 DMS‐IV symptoms of PTSD. Respondents are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they have had with each symptom. The DTS can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD, or scores can be calculated for each of the 3 PTSD symptom clusters. The DTS will be assessed at each study visit (visit 1, 2, 3, 4, 5, 6 and 7). The primary efficacy outcome will be change from baseline (visit 2) to week 5 (visit 7) Secondary outcome measures: Clinician‐administered PTSD Scale (CAPS) (Time frame: 6 weeks. The CAPS was developed at the National Center for PTSD and has become the 'gold standard' for assessing Post Traumatic Stress Disorder. It is a user‐friendly structured interview for screening, differential diagnosis, confirming PTSD diagnosis or identifying Acute Stress Disorder.The CAPS will be assessed at the screening visit and again at week 5 (visit 7). Change scores (from screening to week 5) will be secondary efficacy measures Insomnia Severity Index (ISI) (Time frame: 5 weeks). The ISI is a 7‐item patient‐rated questionnaire that evaluates severity of sleep onset and maintenance difficulties, satisfaction with current sleep pattern interference with daily functioning, appearance of impairment attributed to the sleep problem, and the degree of concern caused by insomnia.Secondary outcome measures using the ISI will be determined using change scores from baseline to week 5 (visit 7)
Starting date	October 2010
Contact information	Study Director: Arifulla Khan, MD., Columbia Northwest Pharmaceuticals, LLC
Notes	Responsible party: Arifulla Khan, MD, Columbia Northwest Pharmaceuticals Estimated primary completion date: June 2011 Estimated study completion date: August 2011

ACE: angiotensin converting enzyme; ALT, AST, ALP: higher than normal; AV: Atrioventricular block; bil: total bilirubin; BZD: benzodiazepines; CAPS‐5: Clinically‐Administered PTSD Scale (CAPS) for DSM‐5; C‐SSRS: Columbia Suicide Severity Rating Scale; DSM‐5: Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; ECG/EKG: ElectroCardiogram; eGFR: Estimated Glomerular Filtration Rate; MADRS: Montgomery‐Asberg Depression Rating Scale; MD: medical doctor; mg: milligrams; M.I.N.I: MINI International Neuropsychiatry Interview; MPH: Master of Public Health; msec: minutes per second; PI: principal investigator; PRN: (pro re nata) as needed; PTSD: posttraumatic stress disorder; QTc: Torsades de Pointes; SAM‐e: s‐adenosyl methionine; SNP: single nucleotide polymorphisms; SNRIs: serotonin and norepinephrine reuptake inhibitors; SSRIs: selective serotonin reuptake inhibitors; ULN: upper limit of normal;