Post-Traumatic Stress DisorderPhase 2NCT01221792
Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)
A Phase 2 study testing Carvedilol in people with Post-Traumatic Stress Disorder, run by Columbia Northwest Pharmaceuticals at 3 sites in United States.
Trial summary
The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- current, unstable and significant medical condition/illness
- bronchial asthma or related bronchospastic condition
- AV block
- Sick Sinus Syndrome
- Bradycardia
- Peripheral hear disease
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwest Clinical Research Center
Bellevue, Washington, 98007
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601
Artemis Institute for Clinical Research
San Diego, California, 92123
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety and Efficacy of Carvedilol Versus Placebo in the Treatment of Post Traumatic Stress Disorder
The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.
Read the detailed description
This initial proof of concept trial design is intended to explore multiple variables. Fist, it is intended to determine if carvedilol has any statistically significant effect over placebo on the various overall symptoms, symptom clusters, or individual symptoms of post traumatic stress disorder. Next, the flexible dosing trial design is aimed to detect the therapeutic dose, or dosing range for carvedilol when used in the treatment of PTSD
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Carvedilol, Placebo
- Keywords
- PTSD, Anxiety, Trauma, Assault, Victim, Witness, Post Traumatic Stress Disorder, Combat veteran, Flashbacks, Nightmares, Sleep Disturbance, Hyperarousal, Numbness, Avoidance
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Wounds and Injuries, Parasomnias, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called Coreg(R)
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).
PlaceboDrug
Non active comparator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 weeks
Secondary outcomes (2)
Clinician Administered PTSD Scale (CAPS)
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, comfirming PTSD diagnosis or identifying Acute Stress Disorder.
The CAPS will be assessed at the screening visit and again at week 5 (vist 7). Change scores (from screening to week 5) will be secondary efficacy measures.
Measured: 6 Weeks
Insomnia Severity Index (ISI)
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)
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia Northwest Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arifulla Khan, MD, Study director, Columbia Northwest Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221792
- Sponsor's protocol ID
- CVD-PT-10203
- Status last verified
- Jun 2011
- First submitted
- 14 Oct 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety and Efficacy of Carvedilol Versus Placebo in the Treatment of Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01221792
- Acronym / sponsor ID
- CVD-PT-10203
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Anxiety, Trauma, Assault, Victim, Witness, Post Traumatic Stress Disorder, Combat veteran
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Columbia Northwest PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.
Detailed description
This initial proof of concept trial design is intended to explore multiple variables. Fist, it is intended to determine if carvedilol has any statistically significant effect over placebo on the various overall symptoms, symptom clusters, or individual symptoms of post traumatic stress disorder. Next, the flexible dosing trial design is aimed to detect the therapeutic dose, or dosing range for carvedilol when used in the treatment of PTSD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carvedilol | Active comparator | Drug: CarvedilolPatients 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. |
| Sugar Pill | Placebo comparator | Drug: PlaceboPatients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- current, unstable and significant medical condition/illness
- bronchial asthma or related bronchospastic condition
- AV block
- Sick Sinus Syndrome
- Bradycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolAlso: Coreg(R)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). | Drug | carvedilol |
| PlaceboNon active comparator | Drug | Sugar Pill |
Primary outcome
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. 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).
2 secondary outcomes
Clinician Administered PTSD Scale (CAPS)
Time frame: 6 Weeks
Insomnia Severity Index (ISI)
Time frame: 5 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arifulla Khan, MD study director
Columbia Northwest Pharmaceuticals, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carvedilol in people with Post-Traumatic Stress Disorder, run by Columbia Northwest Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Davidson Trauma Scale (DTS) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.