PTSDPhase 4NCT00330239
Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence
A Phase 4 study testing Paroxetine CR in people with PTSD, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Pharmacotherapy has demonstrated efficacy in a number of controlled trials in the treatment of PTSD. The selective serotonin reuptake inhibitors have proven particularly useful in treating this disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- Paroxetine CR
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to May 2005
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 65
- Outpatients who meet DSM-IV criteria for PTSD, chronic subtype, based on CAPS-1
- Must have a minimum score of 50 on the CAPS-2 at Baseline
- Must meet DSM-IV criteria for a substance dependence disorder in the last 3 months (excluding caffeine and nicotine)
- Must be able to read English
- Must give written informed consent
Who cannot join
- Individuals with a primary psychiatric disorder other than PTSD
- Individuals with an uncontrolled neurologic condition that could confound the results of the study (e.g. seizure disorder)
- Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize subject safety
- Concomitant use of other psychotropic medications (intermittent use of diphenhydramine and zolpidem will be allowed during the study) see concommitant meds on page 5 of the protocol
- Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
- Individuals who have failed an adequate trial of paroxetine in the past
Show all 11Show fewer
- Current suicidal or homicidal risk
- Currently receiving trauma-specific psychotherapy
- Individuals taking any herbal psychoactive treatments (e.g. St. John's Wart)
- Individuals engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorder
- Individuals, who in the investigator's opinion would be unable to comply with study procedures or assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29464
About this study
Pharmacotherapy has demonstrated efficacy in a number of controlled trials in the treatment of PTSD. The selective serotonin reuptake inhibitors have proven particularly useful in treating this disorder. Currently there are two selective serotonin reuptake inhibitors (Zoloft® and Paxil®), that have been FDA approved for treating PTSD. Coincidentally, this same class of medications has also been shown to have efficacy in some trials in decreasing alcohol consumption in heavy drinkers. The goal of the proposed study is to preliminarily investigate the efficacy of Paxil® (paroxetine), in decreasing symptoms of PTSD as well as decreasing substance use, in individuals with concurrent substance dependence and PTSD. The type of paroxetine used in this trial will be Paxil CR®, which is a sustained release formulation of paroxetine, which has fewer side effects and greater tolerability. This is a particularly important issue in substance using populations because medication compliance is generally poor.
Two specific hypotheses will be tested. 1) Individuals who receive Paxil CR® will have a greater improvement in their PTSD symptoms (based on CAPS-2 and CGI) than those who receive placebo. 2) Individuals who receive Paxil CR® will have greater improvement in their substance use outcomes (based on UDS and TLFB) than will those who receive placebo.
Read the detailed description
Participants who meet all inclusion and no exclusion criteria will be randomized with a 1:1 ratio to receive either Paxil CR or placebo for 12 weeks. Medication will be initiated at 12.5mg/day and will be increased weekly as tolerated to a maximum dose of 50mg/day. Participants will be seen weekly and will be assessed for side effects, substance use since last visit, urine drug screen, breathalyzer readings, vital signs and symptoms of PTSD (TOP-8)at each visit. The Davidson Trauma Scale will be completed every two weeks, and the CAPS-2 and MADRS will be completed monthly. Those who complete the first 12 weeks of double-blind study medication will be eligible to receive open label medication for an additional 12 weeks. Medication will be initiated at 12.5mg and increased every 3 days as tolerated to the terminal dose in the double-blind phase, then adjusted as needed. Participants will come in for assessments every two weeks of the open-label phase. Blood will be drawn for blood chemistries and hematology at screening and weeks 12 and 24. Urine pregnancy tests will be performed for women of childbearing potential at baseline and again at weeks 4, 12 and 24.
- Conditions
- PTSD
- Being tested
- Paroxetine CR
- Keywords
- Substance Abuse, Trauma, Dependence
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine CRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
Clinical Global Impressions Scale
Secondary outcomes (2)
Davidson Trauma Scale
Time-Line Follow-Back
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startJan 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Susan C Sonne, PharmD, Principal investigator, Medical University of South CarolinaKathleen T Brady, MD, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330239
- Sponsor's protocol ID
- CPMS-857
- Status last verified
- Oct 2007
- First submitted
- 25 May 2006
- Last updated
- 3 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence
- ClinicalTrials.gov ID
- NCT00330239
- Acronym / sponsor ID
- CPMS-857
- Conditions
- PTSD
- Keywords
- Substance Abuse, Trauma, Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2003
- Study completion
- May 2005
- First posted
- 26 May 2006 (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.
Pharmacotherapy has demonstrated efficacy in a number of controlled trials in the treatment of PTSD. The selective serotonin reuptake inhibitors have proven particularly useful in treating this disorder. Currently there are two selective serotonin reuptake inhibitors (Zoloft® and Paxil®), that have been FDA approved for treating PTSD. Coincidentally, this same class of medications has also been shown to have efficacy in some trials in decreasing alcohol consumption in heavy drinkers. The goal of the proposed study is to preliminarily investigate the efficacy of Paxil® (paroxetine), in decreasing symptoms of PTSD as well as decreasing substance use, in individuals with concurrent substance dependence and PTSD. The type of paroxetine used in this trial will be Paxil CR®, which is a sustained release formulation of paroxetine, which has fewer side effects and greater tolerability. This is a particularly important issue in substance using populations because medication compliance is generally poor.
Two specific hypotheses will be tested. 1) Individuals who receive Paxil CR® will have a greater improvement in their PTSD symptoms (based on CAPS-2 and CGI) than those who receive placebo. 2) Individuals who receive Paxil CR® will have greater improvement in their substance use outcomes (based on UDS and TLFB) than will those who receive placebo.
Detailed description
Participants who meet all inclusion and no exclusion criteria will be randomized with a 1:1 ratio to receive either Paxil CR or placebo for 12 weeks. Medication will be initiated at 12.5mg/day and will be increased weekly as tolerated to a maximum dose of 50mg/day. Participants will be seen weekly and will be assessed for side effects, substance use since last visit, urine drug screen, breathalyzer readings, vital signs and symptoms of PTSD (TOP-8)at each visit. The Davidson Trauma Scale will be completed every two weeks, and the CAPS-2 and MADRS will be completed monthly. Those who complete the first 12 weeks of double-blind study medication will be eligible to receive open label medication for an additional 12 weeks. Medication will be initiated at 12.5mg and increased every 3 days as tolerated to the terminal dose in the double-blind phase, then adjusted as needed. Participants will come in for assessments every two weeks of the open-label phase. Blood will be drawn for blood chemistries and hematology at screening and weeks 12 and 24. Urine pregnancy tests will be performed for women of childbearing potential at baseline and again at weeks 4, 12 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 to 65
- Outpatients who meet DSM-IV criteria for PTSD, chronic subtype, based on CAPS-1
- Must have a minimum score of 50 on the CAPS-2 at Baseline
- Must meet DSM-IV criteria for a substance dependence disorder in the last 3 months (excluding caffeine and nicotine)
- Must be able to read English
Key exclusion criteria (11 listed)
- Individuals with a primary psychiatric disorder other than PTSD
- Individuals with an uncontrolled neurologic condition that could confound the results of the study (e.g. seizure disorder)
- Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize subject safety
- Concomitant use of other psychotropic medications (intermittent use of diphenhydramine and zolpidem will be allowed during the study) see concommitant meds on page 5 of the protocol
- Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
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 |
|---|---|---|
| Paroxetine CR | Drug | – |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Clinical Global Impressions Scale
2 secondary outcomes
Davidson Trauma Scale
Time-Line Follow-Back
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 3 Oct 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.
Susan C Sonne, PharmD principal investigator
Medical University of South Carolina
Kathleen T Brady, MD, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paroxetine CR in people with PTSD, run by Medical University of South Carolina 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 3 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Clinician Administered PTSD Scale (CAPS). The study lists 2 primary outcomes in all. 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 3 Oct 2007.