DepressionPhase 2TREND1NCT02239809
Electrical Stimulation in Patients With Unipolar Major Depression
A Phase 2 study testing Stimulation of the trigeminal nerve (active stimulation) in people with Depression, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive Disorder. The primary objective is to assess the safety and tolerability of an implantable sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar MDD (Major… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Stimulation of the trigeminal nerve (active stimulation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Jul 2016
- Phase
- Phase 2
- 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
- Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview and legally capacitated to sign the informed consent for participation in the study;
- A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2;
- A history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, 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);
- 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 and lack of self-harming attempt in the past 6 months;
- Patients with appropriate support to be compliant with the study protocol.
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); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
- Patients currently receiving more than six medications for treatment of MDD;
- Patients with exposure to ECT or rTMS or any investigational treatment (for any disorder) within the past 6 months;
- Prior VNS and/or DBS therapy (lifetime);
- 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 during the study, or not using a medically accepted means of contraception;
- Other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blinded Randomized Trial of sTNS as Adjuvant Treatment for Major Unipolar Depressive Disorder.
Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive Disorder. The primary objective is to assess the safety and tolerability of an implantable sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).
- Conditions
- Depression
- Being tested
- Stimulation of the trigeminal nerve (active stimulation), Placebo stimulation of the trigeminal nerve (placebo)
- Keywords
- Electrodes, Implanted, Electric Stimulation Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation of the trigeminal nerve (active stimulation)Procedure or surgery
Also called Electrical Stimulation
Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.
After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks.
Placebo stimulation of the trigeminal nerve (placebo)Procedure or surgery
Also called Sham Eletrical Stimulation
Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks. Patients of the placebo group will be implanted with a lead in the V1 branch of the trigeminal nerve, but will not receive stimulation.
After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
Participants randomized to placebo stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Active comparator | Patients assigned to active stimulation arm will receive electrical stimulation during the study. Receives: Procedure: Stimulation of the trigeminal nerve (active stimulation) |
| Placebo Stimulation | Placebo comparator | Patients assigned to the placebo arm did not receive stimulation electrical stimulation for 24 weeks. After this period the participants randomized to sham stimulation will be moved to the active stimulation and will be followed until study completion. Receives: Procedure: Placebo stimulation of the trigeminal nerve (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify a efficacy of sTNS of the V1 branch of the trigeminal nerve
We will use the Hamilton Rating Scale for Depression (HRSD) 17 scores as the main outcome measure to assess the efficacy of sTNS of the V1 branch of the trigeminal nerve as adjunctive treatment for MDD.
Measured: 12 months
Secondary outcomes (3)
Identify the tolerability of sTNS stimulation
Tolerability will be evaluated by the records of adverse effects observed during the randomized, open stimulation. We will apply the Ugvalg for Kliniske Undersgelser (UKU) scale at all visits for all patients and to compare scores between groups. Adverse events will be categorized using the MedDRA Medical Dictionary for Regulatory Activities. Complications reported by active and sham stimulation groups will be compared. The complication risk will be calculated based on the overall study duration.
Measured: 12 months
Identify the long-term recurrence rate of sTNS therapy
We will calculate the recurrence rate of all participants at the end of the open label prospective follow-up. Recurrence is defined as return of HAM-17 scores equal to or superior to the original, after the patient has lodged during partial response (20% decrease of the initial score) or complete response (50% decrease of the initial score).
Measured: 12 months
Identify the duration of the placebo effect
To evaluate the duration of the placebo effect in participants randomized to sham stimulation during the initial 12 weeks of the trial. The mean, median and the standard deviation of the interval time to recurrence will be calculated on placebo stimulation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionJul 2016
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra Gorgulho, MD, MSc, Principal investigator, Hospital do CoracaoAntonio De Salles, M.D., Ph.D., Principal investigator, Hospital do CoraçãoOtavio Berwanger, MD,PhD, Study director, Hospital do Coração
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239809
- Sponsor's protocol ID
- 239/2012
- Acronym
- TREND1
- Status last verified
- Sep 2016
- First submitted
- 21 Aug 2014
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Trial of sTNS as Adjuvant Treatment for Major Unipolar Depressive Disorder.
- ClinicalTrials.gov ID
- NCT02239809
- Acronym / sponsor ID
- TREND1 / 239/2012
- Conditions
- Depression
- Keywords
- Electrodes, Implanted, Electric Stimulation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Sep 2014 (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.
Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive Disorder. The primary objective is to assess the safety and tolerability of an implantable sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Active comparator | Procedure: Stimulation of the trigeminal nerve (active stimulation)Patients assigned to active stimulation arm will receive electrical stimulation during the study. |
| Placebo Stimulation | Placebo comparator | Procedure: Placebo stimulation of the trigeminal nerve (placebo)Patients assigned to the placebo arm did not receive stimulation electrical stimulation for 24 weeks. After this period the participants randomized to sham stimulation will be moved to the active stimulation and will be followed until study completion. |
Who may qualify
- Ages
- 18 to 65 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 assessed via the MINI structured interview and legally capacitated to sign the informed consent for participation in the study;
- A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2;
- A history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, 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);
- 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 and lack of self-harming attempt in the past 6 months;
- Patients with appropriate support to be compliant with the study protocol.
Key exclusion criteria (8 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); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
- Patients currently receiving more than six medications for treatment of MDD;
- Patients with exposure to ECT or rTMS or any investigational treatment (for any disorder) within the past 6 months;
- Prior VNS and/or DBS therapy (lifetime);
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 |
|---|---|---|
| Stimulation of the trigeminal nerve (active stimulation)Also: Electrical StimulationParticipants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks. After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study. Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study. The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks. | Procedure or surgery | Active Stimulation |
| Placebo stimulation of the trigeminal nerve (placebo)Also: Sham Eletrical StimulationParticipants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks. Patients of the placebo group will be implanted with a lead in the V1 branch of the trigeminal nerve, but will not receive stimulation. After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study. Participants randomized to placebo stimulation will be shifted to active stimulation and will be followed-up until completion of the study. The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks. | Procedure or surgery | Placebo Stimulation |
Primary outcome
Identify a efficacy of sTNS of the V1 branch of the trigeminal nerve
Time frame: 12 months
We will use the Hamilton Rating Scale for Depression (HRSD) 17 scores as the main outcome measure to assess the efficacy of sTNS of the V1 branch of the trigeminal nerve as adjunctive treatment for MDD.
3 secondary outcomes
Identify the tolerability of sTNS stimulation
Time frame: 12 months
Identify the long-term recurrence rate of sTNS therapy
Time frame: 12 months
Identify the duration of the placebo effect
Time frame: 12 months
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 29 Sep 2016.
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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.
Alessandra Gorgulho, MD, MSc principal investigator
Hospital do Coracao
Antonio De Salles, M.D., Ph.D. principal investigator
Hospital do Coração
Otavio Berwanger, MD,PhD study director
Hospital do Coração
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stimulation of the trigeminal nerve (active stimulation) in people with Depression, run by Hospital do Coracao at 1 site in Brazil.
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 8 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 29 Sep 2016. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Identify a efficacy of sTNS of the V1 branch of the trigeminal nerve (time frame: 12 months). 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 29 Sep 2016.