Chronic Posttraumatic Stress DisorderNCT01024140
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
A study testing Escitalopram in people with Chronic Posttraumatic Stress Disorder, run by Northern California Institute of Research and Education.
Trial summary
The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Chronic Posttraumatic Stress Disorder
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Dec 2004
- Phase
- Interventional
- 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 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Current DSM-IV TR PTSD and a score > 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.
Who cannot join
- Lifetime history of bipolar or any psychiatric disorder with psychotic features.
- Prominent suicidal or homicidal ideation.
- History of alcohol abuse/dependence within the past 3 months.
- History of drug abuse/dependence within the past 6 months.
- Subjects who plan to start a new form of psychotherapy during the protocol.
- History of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function.
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- History of myocardial infarction in the past year.
- Subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
- Use of Citalopram or Escitalopram within the past 6 months.
About this study
The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.
A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.
- Conditions
- Chronic Posttraumatic Stress Disorder
- Being tested
- Escitalopram
- Keywords
- Posttraumatic Stress Disorder, Escitalopram, Efficacy
- 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.
EscitalopramDrug
Also called Lexapro
Subjects were started on 5mg escitalopram. Medication was increased as tolerated in weekly 2.5, 5 or 10 mg increments, until a maximally tolerated dosage or a clinical response was achieved. The final dosage ranged from 5 to 20 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Flexible dose (5-20mg/day) of escitalopram monotherapy. Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinician Administered PTSD Scale
Measured: Administered at baseline (prior to treatment) and week 12
Secondary outcomes (5)
PTSD Checklist
Measured: Each Visit: Week 0, 2, 4, 6, 8, & 12
Beck Depression Inventory
Measured: Each Visit: Week 0, 2, 4, 6, 8, & 12
Profile of Mood State
Measured: Each Visit: Week 0, 2, 4, 6, 8, & 12
Social Adjustment Scale
Measured: Initial, Mid-Trial and Final Assessments
Quality of Life Inventory
Measured: Initial, Mid-Trial and Final Assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startFeb 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Posttraumatic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern California Institute of Research and Education
- Sponsor type
- University, hospital or other
- Investigators
- Thomas C Neylan, MD, Principal investigator, UCSF / VAMC / NCIRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024140
- Sponsor's protocol ID
- NEY-608
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01024140
- Acronym / sponsor ID
- NEY-608
- Conditions
- Chronic Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Escitalopram, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northern California Institute of Research and EducationUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 2 Dec 2009 (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 primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.
A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: EscitalopramFlexible dose (5-20mg/day) of escitalopram monotherapy. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current DSM-IV TR PTSD and a score > 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.
Key exclusion criteria (9 listed)
- Lifetime history of bipolar or any psychiatric disorder with psychotic features.
- Prominent suicidal or homicidal ideation.
- History of alcohol abuse/dependence within the past 3 months.
- History of drug abuse/dependence within the past 6 months.
- Subjects who plan to start a new form of psychotherapy during the protocol.
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 |
|---|---|---|
| EscitalopramAlso: LexaproSubjects were started on 5mg escitalopram. Medication was increased as tolerated in weekly 2.5, 5 or 10 mg increments, until a maximally tolerated dosage or a clinical response was achieved. The final dosage ranged from 5 to 20 mg/day. | Drug | Escitalopram |
Primary outcome
The Clinician Administered PTSD Scale
Time frame: Administered at baseline (prior to treatment) and week 12
5 secondary outcomes
PTSD Checklist
Time frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
Beck Depression Inventory
Time frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
Profile of Mood State
Time frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
Social Adjustment Scale
Time frame: Initial, Mid-Trial and Final Assessments
Quality of Life Inventory
Time frame: Initial, Mid-Trial and Final Assessments
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 2 Dec 2009.
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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.
Thomas C Neylan, MD principal investigator
UCSF / VAMC / NCIRE
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Chronic Posttraumatic Stress Disorder, run by Northern California Institute of Research and Education.
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 1 inclusion and 9 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 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The Clinician Administered PTSD Scale (time frame: Administered at baseline (prior to treatment) and week 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 2 Dec 2009.