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Trial record 3 of 5 for:    etns

Electrical Stimulation in Patients With Unipolar Major Depression (TREND2)

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ClinicalTrials.gov Identifier: NCT02239822
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

Brief Summary:
Double Blinded Randomized Trial of eTNS as adjuvant treatment for Major Unipolar Depressive Disorder. The primary objective is to assess the safety and tolerability of eTNS (external trigeminal nerve stimulation) of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).

Condition or disease Intervention/treatment Phase
Depression Procedure: Stimulation of the trigeminal nerve (active stimulation) Procedure: Placebo stimulation of the trigeminal nerve (placebo) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double Blinded Randomized Trial of eTNS as Adjuvant Treatment for Major Unipolar Depressive Disorder.
Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

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Arm Intervention/treatment
Active Comparator: Active Stimulation
Patients assigned to active stimulation arm will receive electrical stimulation during the study.
Procedure: Stimulation of the trigeminal nerve (active 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. the duration of the open label trial will be more 24 weeks.

Other Name: Electrical Stimulation

Placebo Comparator: Placebo Stimulation
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.
Procedure: Placebo stimulation of the trigeminal nerve (placebo)

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.

Other Name: Sham Eletrical Stimulation




Primary Outcome Measures :
  1. Identify a efficacy of eTNS of the V1 branch of the trigeminal nerve [ Time Frame: 48 weeks ]
    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.


Secondary Outcome Measures :
  1. Identify the tolerability of eTNS stimulation [ Time Frame: 48 weeks ]
    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.

  2. Identify the long-term recurrence rate of eTNS therapy [ Time Frame: 48 weeks ]
    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).

  3. Identify the duration of the placebo effect [ Time Frame: 48 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239822


Locations
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Brazil
Hospital do Coracao
São Paulo, SP, Brazil, 04005-000
Sponsors and Collaborators
Hospital do Coracao
Investigators
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Principal Investigator: Alessandra Gorgulho, MD, MSc HOSPITAL DO CORAÇÃO
Principal Investigator: Antonio De Salles, M.D., Ph.D. HOSPITAL DO CORAÇÃO
Study Director: Otavio Berwanger, MD,PhD HOSPITAL DO CORAÇÃO

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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT02239822     History of Changes
Other Study ID Numbers: 271/2013
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Keywords provided by Hospital do Coracao:
Electrodes, Implanted
Electric Stimulation Therapy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders