Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)

NCT01221792 | Unknown Phase 2

• 1 other identifier: CVD-PT-10203
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD; Anxiety; Trauma; Assault; Victim; Witness; Post Traumatic Stress Disorder; Combat veteran; Flashbacks; Nightmares; Sleep Disturbance; Hyperarousal; Numbness; Avoidance

Outcome Measures

Primary Outcomes (1)

• Davidson Trauma Scale (DTS)

  The DTS is a 17-item self report measure to assess the 17 DMS-IV symptoms of PTSD. Respondants are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they hav had with each symptom. The DTS can be used to make a preliminatry 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).

  5 weeks

Secondary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS)

  6 Weeks

• Insomnia Severity Index (ISI)

  5 Weeks

Study Arms (2)

carvedilol

ACTIVE COMPARATOR

Patients randomized to carvedilol will be administered doses ranging from 6.25 to 15.625 mg/day using a flexible-dosing model. After a 1 week titration, investigators my increase daily dose by 6.25 mg/day at weeks 1 and 2 for a maximum dose of 15.625 mg/day. Weeks 3-4 will patients will remain on a stable, tolerable dose. At week 5 patients will have a 1 week taper.

Drug: Carvedilol

Sugar Pill

PLACEBO COMPARATOR

Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.

Drug: Placebo

Interventions

Carvedilol DRUG

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).

Also known as: Coreg(R)

carvedilol

Placebo DRUG

Non active comparator

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Females who are pregnant, lactating or planning to become pregnant
• Bipolar
• Schizophrenia
• Dementia
• Intolerance or hypersensitivity to alpha or beta blockers

Sponsors & Collaborators

• Columbia Northwest Pharmaceuticals: lead

Study Sites (3)

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70601, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Wounds and Injuries; Parasomnias; Hypesthesia

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Arifulla Khan, MD

  Columbia Northwest Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 15, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (3)