Posttraumatic Stress DisordersPhase 3NCT00583193
Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic Stress Disorder
A Phase 3 study testing Duloxetine hydrochloride in people with Posttraumatic Stress Disorders, run by Canive, Jose M., M.D. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Duloxetine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jun 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ages 18 or older of any ethnic background meeting DSM-IV criteria for PTSD
- Score of at least 60 on the CAPS-SX at baseline
- Competent to give informed consent
- If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential
- Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the baseline visit (treatment phase); two weeks prior in the case of fluoxetine or in the case of an MAOI
- Other medications, if any, must have been kept stable for at least one month prior to the baseline visit
Who cannot join
- Known hypersensitivity to duloxetine or any of the inactive ingredients
- Females who are pregnant or breastfeeding
- Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to the baseline visit and throughout the study period
- Use of fluoxetine or an MAOI within two weeks
- Concomitant use of narrow therapeutic index medications or medications that are likely to have a clinically significant drug interaction with duloxetine
- Medical conditions that may prevent safe administration of duloxetine including end stage renal disease, clinically significant renal impairment (CrCl <30 mL/min), hepatic insufficiency, cardiac disease, or pulmonary disease
Show all 13Show fewer
- Patients with uncontrolled narrow-angle glaucoma
- Alcohol or drug abuse or dependence within three months of study entry as defined by DSM-IV criteria
- Alcohol use may not exceed 12 drinks per week or 5 drinks per drinking episode during the course of the study.
- A current or past history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder
- Suicidal or homicidal ideation or other clinically significant dangerous behavior
- Currently seeking compensation or increase in compensation for the effects of the trauma
- Initiation or change in psychotherapy within 3 months of study entry
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
Jose M Canive, M.D.
About this study
Official title: A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.
The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).
Read the detailed description
Duloxetine has established efficacy for treatment of major depression, generalized anxiety disorder and diabetic peripheral neuropathic pain. Chronic PTSD is often treated with antidepressants, in fact there are only two FDA-approved treatments for PTSD. Yet many chronic PTSD patients, especially male combat veterans, have a limited response to antidepressant treatment (Baker et al, 1995; Cañive et al, 1998; Hertzsberg et al 2000) and new pharmacotherapies should be investigated.
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Duloxetine hydrochloride
- Keywords
- Post Traumatic Stress Disorder, Duloxetine, Antidepressants
- 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.
Duloxetine hydrochlorideDrug
Also called Cymbalta
Start 30 mg Q.D. for 7 days, then increased to 60 mg Q.D. @ the week 1 visit. Thereafter, dose may be increased or decreased by 30 mg increments based on tolerability and efficacy between a dosage range of 60 to 120 mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Open-label Study Receives: Drug: Duloxetine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Measured: Performed at baseline, weeks 1, 2, 4, 8, & 12
Secondary outcomes (1)
Visual Analog Scale for Pain (VAS)
Measured: Baseline, weeks 1, 2, 4, 8, & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startDec 2005
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canive, Jose M., M.D.
- Collaborators
- Eli Lilly and Company
- Investigators
- Jose M Canive, M.D., Principal investigator, New Mexico VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583193
- Sponsor's protocol ID
- F1J-US-X024
- Status last verified
- Dec 2007
- First submitted
- 20 Dec 2007
- Last updated
- 31 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.
- ClinicalTrials.gov ID
- NCT00583193
- Acronym / sponsor ID
- F1J-US-X024
- Conditions
- Posttraumatic Stress Disorders
- Keywords
- Post Traumatic Stress Disorder, Duloxetine, Antidepressants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Canive, Jose M., M.D.
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 2005
- Study completion
- Jun 2008 (estimated)
- First posted
- 31 Dec 2007 (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 purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).
Detailed description
Duloxetine has established efficacy for treatment of major depression, generalized anxiety disorder and diabetic peripheral neuropathic pain. Chronic PTSD is often treated with antidepressants, in fact there are only two FDA-approved treatments for PTSD. Yet many chronic PTSD patients, especially male combat veterans, have a limited response to antidepressant treatment (Baker et al, 1995; Cañive et al, 1998; Hertzsberg et al 2000) and new pharmacotherapies should be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Duloxetine hydrochlorideOpen-label Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients ages 18 or older of any ethnic background meeting DSM-IV criteria for PTSD
- Score of at least 60 on the CAPS-SX at baseline
- Competent to give informed consent
- If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential
- Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the baseline visit (treatment phase); two weeks prior in the case of fluoxetine or in the case of an MAOI
Key exclusion criteria (13 listed)
- Known hypersensitivity to duloxetine or any of the inactive ingredients
- Females who are pregnant or breastfeeding
- Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to the baseline visit and throughout the study period
- Use of fluoxetine or an MAOI within two weeks
- Concomitant use of narrow therapeutic index medications or medications that are likely to have a clinically significant drug interaction with duloxetine
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 |
|---|---|---|
| Duloxetine hydrochlorideAlso: CymbaltaStart 30 mg Q.D. for 7 days, then increased to 60 mg Q.D. @ the week 1 visit. Thereafter, dose may be increased or decreased by 30 mg increments based on tolerability and efficacy between a dosage range of 60 to 120 mg. | Drug | 1 |
Primary outcome
PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Time frame: Performed at baseline, weeks 1, 2, 4, 8, & 12
1 secondary outcome
Visual Analog Scale for Pain (VAS)
Time frame: Baseline, weeks 1, 2, 4, 8, & 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2007.
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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.
Jose M Canive, M.D. principal investigator
New Mexico VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine hydrochloride in people with Posttraumatic Stress Disorders, run by Canive, Jose M., M.D. 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 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 31 Dec 2007. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Lawrence A Calais, R.N. (505-265-1711 ext. 2677, lawrence.calais@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS) (time frame: Performed at baseline, weeks 1, 2, 4, 8, & 12). 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 31 Dec 2007.