Clinical trial NCT02239809: Electrical Stimulation in Patients With Unipolar Major Depression
Official title: Double Blinded Randomized Trial of sTNS as Adjuvant Treatment for Major Unipolar Depressive Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Electrodes, Implanted
Electric Stimulation Therapy
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Depressive Disorder).


Eligibility 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.

Primary outcomes:
measure: Identify a efficacy of sTNS of the V1 branch of the trigeminal nerve
timeFrame: 12 months
Secondary outcomes:
measure: Identify the tolerability of sTNS stimulation
timeFrame: 12 months
measure: Identify the long-term recurrence rate of sTNS therapy
timeFrame: 12 months
measure: Identify the duration of the placebo effect
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
Study officials:
affiliation: Hospital do Coracao
name: Alessandra Gorgulho, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coração
name: Antonio De Salles, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coração
name: Otavio Berwanger, MD,PhD
role: STUDY_DIRECTOR
References: