DepressionPhase 1NCT01335217
Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression
A Phase 1 study testing Transcutaneous Electrical Nerve Stimulator (TENS) in people with Depression and Post-traumatic Stress Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression, Post-traumatic Stress Disorder
- What is being tested?
- Transcutaneous Electrical Nerve Stimulator (TENS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- Phase
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with non-psychotic, unipolar Major Depressive Disorder AND Posttraumatic Stress Disorder, assessed via the MINI structured interview
- A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
- A score of ≥ 50 on the CAPS (Clinical-Administered PTSD Scale for DSM-IV)
- A history of treatment failure with at least one adequate trial of an antidepressant over the previous 6 weeks, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study)
- Age range: 18 to 75. 6) Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.
Who cannot join
- Patient is mentally or legally incapacitated, unable to give informed consent.
- Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive- compulsive disorder (lifetime); acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
- Patients with exposure to ECT or VNS within the past 6 months.
- Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
- current pregnancy, breast feeding, plans to become pregnant in the 12-week treatment phase of the study, or not using a medically accepted means of contraception.
- Other medical contraindications to any of the study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Semel Institute for Neuroscience and Human Behavior at UCLA
Los Angeles, California, 90024
About this study
Official title: Trigeminal Nerve Stimulation for PTSD and Depression
This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary objective is the examination of TNS in this patient population.
To accomplish our specific aims, the investigators will test the following specific hypotheses:
- Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period.
- Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
- Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
Read the detailed description
A total of 20 subjects with Major Depressive Disorder (MDD) co-occurring with Post Traumatic Stress Disorder (PTSD), ages 18 to 75 years, will be consented and join this project at UCLA.
The project will use TNS in under open-label conditions, using the same stimulation parameters as have been used in prior studies in MDD by itself and in treatment-refractory epilepsy. Subjects will be seen every two weeks during the 8 week study. At the end of the 8 weeks, the TNS systems will be returned and the adjunctive treatment will end. The co-primary endpoints are the changes in depression severity and in PTSD severity from enrollment to the week 8 visit.
- Conditions
- Depression, Post-traumatic Stress Disorder
- Being tested
- Transcutaneous Electrical Nerve Stimulator (TENS)
- Keywords
- Depression, Major Depressive Disorder (MDD), Trigeminal Nerve Stimulation, Post Traumatic Stress Disorder
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulator (TENS)Procedure or surgery
External trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications
| Study group | Role | What they receive |
|---|---|---|
| Open-label TNS treatment | Other | There is only one arm in this open label treatment of MDD co-occuring with PTSD. Receives: Procedure: Transcutaneous Electrical Nerve Stimulator (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale-17 Item
Measured: Baseline, week 8
Change in PTSD Checklist score
Measured: Baseline, Week 8
Secondary outcomes (3)
Change in life functional capacity and quality of life scales
Life functional capacity and quality of life scales include: Short-form Health Survey-36 Item and Quality of Life Enjoyment and Satisfaction Questionnaire
Measured: baseline, week 8
Changes in vital signs recordings
Autonomic function (i.e. pulse and blood pressure) are monitored for 30 mins of stimulation at baseline. Resting vital signs are recorded for each visit.
Measured: At every visit for 8 weeks
Changes in Safety Assessment Measures
Safety Assessment measures will be administered at each visit and include: Survey of Acceptability of TNS, Systematic Assessment for Treatment Emergent Events-Systematic Inquiry (SAFTEE-SI), and Frequency, Intensity, and Burden of Side Effects Scale (FIBSER)
Measured: At every visit for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian A. Cook, M.D., University of California, Los Angeles
- Investigators
- Ian A Cook, M.D., Principal investigator, Semel Institute for Neuroscience and Human Behavior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335217
- Sponsor's protocol ID
- 10-000894
- Other IDs
- 10-000894
- Status last verified
- Feb 2013
- First submitted
- 5 Apr 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigeminal Nerve Stimulation for PTSD and Depression
- ClinicalTrials.gov ID
- NCT01335217
- Acronym / sponsor ID
- 10-000894
- Conditions
- Depression, Post-traumatic Stress Disorder
- Keywords
- Depression, Major Depressive Disorder (MDD), Trigeminal Nerve Stimulation, Post Traumatic Stress Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Apr 2011 (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.
This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary objective is the examination of TNS in this patient population.
To accomplish our specific aims, the investigators will test the following specific hypotheses:
- Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period.
- Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
- Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
Detailed description
A total of 20 subjects with Major Depressive Disorder (MDD) co-occurring with Post Traumatic Stress Disorder (PTSD), ages 18 to 75 years, will be consented and join this project at UCLA.
The project will use TNS in under open-label conditions, using the same stimulation parameters as have been used in prior studies in MDD by itself and in treatment-refractory epilepsy. Subjects will be seen every two weeks during the 8 week study. At the end of the 8 weeks, the TNS systems will be returned and the adjunctive treatment will end. The co-primary endpoints are the changes in depression severity and in PTSD severity from enrollment to the week 8 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label TNS treatment | Other | Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)There is only one arm in this open label treatment of MDD co-occuring with PTSD. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients with non-psychotic, unipolar Major Depressive Disorder AND Posttraumatic Stress Disorder, assessed via the MINI structured interview
- A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
- A score of ≥ 50 on the CAPS (Clinical-Administered PTSD Scale for DSM-IV)
- A history of treatment failure with at least one adequate trial of an antidepressant over the previous 6 weeks, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study)
- Age range: 18 to 75. 6) Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.
Key exclusion criteria (6 listed)
- Patient is mentally or legally incapacitated, unable to give informed consent.
- Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive- compulsive disorder (lifetime); acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
- Patients with exposure to ECT or VNS within the past 6 months.
- Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
- current pregnancy, breast feeding, plans to become pregnant in the 12-week treatment phase of the study, or not using a medically accepted means of contraception.
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulator (TENS)External trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications | Procedure or surgery | Open-label TNS treatment |
Primary outcome
Change in Hamilton Depression Rating Scale-17 Item
Time frame: Baseline, week 8
Change in PTSD Checklist score
Time frame: Baseline, Week 8
3 secondary outcomes
Change in life functional capacity and quality of life scales
Time frame: baseline, week 8
Changes in vital signs recordings
Time frame: At every visit for 8 weeks
Changes in Safety Assessment Measures
Time frame: At every visit for 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 6 Feb 2013.
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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.
Ian A Cook, M.D. principal investigator
Semel Institute for Neuroscience and Human Behavior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcutaneous Electrical Nerve Stimulator (TENS) in people with Depression and Post-traumatic Stress Disorder, run by University of California, Los Angeles 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 5 inclusion and 6 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 6 Feb 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in Hamilton Depression Rating Scale-17 Item (time frame: Baseline, week 8). 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 6 Feb 2013.