Posttraumatic Stress DisorderEarly Phase 1NCT00763178
Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)
A Early Phase 1 study testing Duloxetine in people with Posttraumatic Stress Disorder, run by Yale University at 1 site in United States.
Trial summary
Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2009
- Phase
- Early Phase 1
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PTSD (age range 18-65 years) as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, non-patient version (First et al., 1996)
- Willingness to participate in a naturalistic treatment study using duloxetine and in two fear conditioning tests, one at baseline and one at the end of the 8 weeks treatment study. We will include PTSD subjects on medications (possible medications include antidepressants, benzodiazepines, and neuroleptics) who have no or only partial treatment response or PTSD patients who are untreated. Treatment will be switched to duloxetine and the previous antidepressant medication will be discontinued.
- PTSD subjects will have a minimum score of 50 on the Clinician-Administered PTSD Scale (CAPS; Blake et al, 1995).
- Participants will be enrolled until the number of 20 subjects who complete the study is reached.
- All subjects are required to be in a medically stable condition as determined by a thorough physical examination, including ECG, blood work and urine analysis.
- No vulnerable subjects will be recruited for this study.
Who cannot join
- comorbid diagnosis of bipolar illness, schizophrenia or other psychotic disorders or presence of psychotic symptoms
- acute or chronic suicidality
- acute or chronic unstable medical conditions (including severely impaired hepatic function as indicated with abnormal PT and PTT, abnormal CBC, and liver enzymes more than 50% above the upper normal range, not well controlled blood pressure)
- current diagnosis of substance abuse or dependence
- unsuccessful treatment history with duloxetine, known hypersensitivity to duloxetine or any of its inactive ingredients
- administration of any investigational drug up to 90 days before entry into the study
Show all 11Show fewer
- intake of monoamino oxides inhibitors up to 90 days before entry into the study or during the study
- subjects with a positive screen for drugs of abuse
- no startle or skin conductance response, or excessively high startle response to the startle probe (100 dB acoustic stimuli) during the pretest
- patients with uncontrolled narrow-angle glaucoma
- Pregnant as indicated by urine pregnancy test or unwillingness to prevent conception during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Effects of Duloxetine on Fear Conditioning in PTSD
Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin reuptake inhibitors (SRIs) are considered treatment of first choice for these patients, however a substantial portion of patients treated with SRIs do not respond sufficiently. Therefore, there is a need to establish novel and effective treatment strategies for these patients. Recently, duloxetine has received considerable attention since it was shown in multiple controlled trials to be an effective treatment for people with major depressive disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the psychophysiological responses at baseline and in response to treatment with duloxetine have been inadequately studied and may provide novel insight into antidepressant and anxiolytic mechanisms of this compound.
Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD.
Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Duloxetine
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Dosage given according to the following schedule:
Week 1: 30mg QD, Week 2: 60mg QD, Week 3: 60mg QD, Week 4-6: Flexible dosing according to clinical situation, dose range between 60-120mg QD, Weeks 7 + 8: fixed dose
| Study group | Role | What they receive |
|---|---|---|
| PTSD | Experimental | Duloxetine Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startFeb 2007
- Primary completionApr 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Responsible party
- Sponsor
- Investigators
- Alexander Neumeister, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763178
- Sponsor's protocol ID
- 0612002110
- Other IDs
- M120627
- Status last verified
- Apr 2015
- First submitted
- 25 Dec 2007
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Duloxetine on Fear Conditioning in PTSD
- ClinicalTrials.gov ID
- NCT00763178
- Acronym / sponsor ID
- 0612002110
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Study start
- Feb 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Sep 2008 (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.
Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin reuptake inhibitors (SRIs) are considered treatment of first choice for these patients, however a substantial portion of patients treated with SRIs do not respond sufficiently. Therefore, there is a need to establish novel and effective treatment strategies for these patients. Recently, duloxetine has received considerable attention since it was shown in multiple controlled trials to be an effective treatment for people with major depressive disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the psychophysiological responses at baseline and in response to treatment with duloxetine have been inadequately studied and may provide novel insight into antidepressant and anxiolytic mechanisms of this compound.
Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD.
Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTSD | Experimental | Drug: DuloxetineDuloxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with PTSD (age range 18-65 years) as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, non-patient version (First et al., 1996)
- Willingness to participate in a naturalistic treatment study using duloxetine and in two fear conditioning tests, one at baseline and one at the end of the 8 weeks treatment study. We will include PTSD subjects on medications (possible medications include antidepressants, benzodiazepines, and neuroleptics) who have no or only partial treatment response or PTSD patients who are untreated. Treatment will be switched to duloxetine and the previous antidepressant medication will be discontinued.
- PTSD subjects will have a minimum score of 50 on the Clinician-Administered PTSD Scale (CAPS; Blake et al, 1995).
- Participants will be enrolled until the number of 20 subjects who complete the study is reached.
- All subjects are required to be in a medically stable condition as determined by a thorough physical examination, including ECG, blood work and urine analysis.
Key exclusion criteria (11 listed)
- comorbid diagnosis of bipolar illness, schizophrenia or other psychotic disorders or presence of psychotic symptoms
- acute or chronic suicidality
- acute or chronic unstable medical conditions (including severely impaired hepatic function as indicated with abnormal PT and PTT, abnormal CBC, and liver enzymes more than 50% above the upper normal range, not well controlled blood pressure)
- current diagnosis of substance abuse or dependence
- unsuccessful treatment history with duloxetine, known hypersensitivity to duloxetine or any of its inactive ingredients
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 |
|---|---|---|
| DuloxetineAlso: CymbaltaDosage given according to the following schedule: Week 1: 30mg QD, Week 2: 60mg QD, Week 3: 60mg QD, Week 4-6: Flexible dosing according to clinical situation, dose range between 60-120mg QD, Weeks 7 + 8: fixed dose | Drug | PTSD |
Primary outcome
Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
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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.
Alexander Neumeister, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Duloxetine in people with Posttraumatic Stress Disorder, run by Yale University at 1 site 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD (time frame: 8 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 23 Apr 2015.