NCT01973478

Brief Summary

Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important. Patients with TRD are potential candidates for neurosurgical interventions to treat depression. However, psychosurgery interventions based upon lesions, showed their limitations related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of course 3. the irreversible damage caused by the surgery. Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

June 3, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

3.1 years

First QC Date

October 8, 2013

Last Update Submit

December 26, 2019

Conditions

Major Depressive DisorderRecurrent Depressive DisorderBipolar Disorder

Keywords

Major depressive disorderRecurrent depressive disorderBipolar disorderDeep brain stimulationAccumbens

Outcome Measures

Primary Outcomes (1)

  • Response = 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version) (yes/no)

    Response is defined as a 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version)

    Month 7

Secondary Outcomes (12)

  • Remission (yes/no)

    Month 7

  • CGI (Clinical global impressions) amelioration (yes/no)

    Month 7

  • GAF (Global assessment of functioning)

    Month 7

  • HDRS-17 (Hamilton depression rating scale, 17 items version)

    Month 7

  • MADRS (Montgomery-Asberg Depression Rating Scale)

    Month 7

  • +7 more secondary outcomes

Other Outcomes (10)

  • HDRS-17 (Hamilton depression rating scale, 17 items version)

    Month -3 ; Month -1; Day -7; Day 15; Month 1; Day 45; Month 2 ; Day 75 ; Month 3; Month 4; Month 5; Month 6; Month 7; Month 8; Month 9; Month 10; Month 13; Month 16; Month 19; Month 22; Month 24

  • MADRS (Montgomery-Asberg Depression Rating Scale)

    Month -3 ; Month -1; Day -7; Day 15; Month 1; Day 45; Month 2 ; Day 75 ; Month 3; Month 4; Month 5; Month 6; Month 7; Month 8; Month 9; Month 10; Month 13; Month 16; Month 19; Month 22; Month 24

  • BDI (Beck Depression Inventory)

    Day -7; Day 15; Month 1; Day 45; Month 2 ; Day 75 ; Month 3; Month 4; Month 5; Month 6; Month 7; Month 8; Month 9; Month 10; Month 13; Month 16; Month 19; Month 22; Month 24

  • +7 more other outcomes

Study Arms (2)

DBS

EXPERIMENTAL

The medical device includes: * Either a pacemaker ACTIVA PC (Ref 37601) two-channel (Medtronic USA) or two pacemakers Activa SC (Ref 37603) to a channel (Medtronic USA) * Two DBS electrodes with four contacts (type Medtronic DBS 3389). Patients will be operated with the usual stereotactic surgical procedure. The target is the Accumbens nucleus. The two electrodes are implanted in a single session under local anaesthesia or intermittent sedation (propofol parenteral without intubation early intervention). Day 0 is defined by the surgery. The DBS is "on" during 6 months (between Month 1 and Month 7). Stimulation will also be on after Month 7.

Device: DBS

SHAM

SHAM COMPARATOR

The medical device includes: * Either a pacemaker ACTIVA PC (Ref 37601) two-channel (Medtronic USA) or two pacemakers Activa SC (Ref 37603) to a channel (Medtronic USA) * Two DBS electrodes with four contacts (type Medtronic DBS 3389). Patients will be operated with the usual stereotactic surgical procedure. The target is the Accumbens nucleus. The two electrodes are implanted in a single session under local anaesthesia or intermittent sedation (propofol parenteral without intubation early intervention). Day 0 is defined by the surgery. The DBS is "off" during 6 months (between Month 1 and Month 7). Possibility to active the stimulation after Month 7.

Device: SHAM

Interventions

DBSDEVICE
DBS
SHAMDEVICE
SHAM

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years
  • DSM-IV (DSM = Diagnostic and Statistical Manual) criteria for a recurrent depressive disorder or bipolar disorder
  • Duration of the episode \> 2 years
  • Severity of the episode attested by :
  • A HDRS score \> 21
  • A CGI score ≥ 4
  • A GAF \< 50
  • Persistence of severity criteria during the screening
  • Following characteristics resistance in case of recurrent depressive disorder :
  • Stage V of the classification of Thase and Rush
  • Unsuccessful treatment by the association of two antidepressants (or intolerance/contra-indications)
  • Unsuccessful treatment by the association for at least 6 weeks of one of the following treatments : lithium , thyroid hormone , buspirone , pindolol with an antidepressant (or intolerance/contra-indications)
  • Unsuccessful treatment by the combination of a second-generation antipsychotic (olanzapine, risperidone, amisulpride, aripiprazole, clozapine and quetiapine) to an antidepressant (or intolerance/contra-indications)
  • Unsuccessful treatment by a structured psychotherapy
  • Following characteristics of resistance in case of bipolar disorder:
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

APHM

Marseille, France

Location

APHP Pitié Salpetriere

Paris, France

Location

CHS

Poitiers, France

Location

CHS

Rouen, France

Location

CHU

Toulouse, France

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive DisorderBipolar Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBipolar and Related Disorders

Study Officials

  • Jean Michel Reymann

    CIC INSERM 0203 CHU Rennes

    STUDY CHAIR

  • Florian Naudet

    CIC INSERM 0203 CHU Rennes

    STUDY CHAIR

  • Bruno Millet

    Groupe Hospitalier Pitié-Salpêtrière

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 31, 2013

Study Start

June 3, 2014

Primary Completion

July 3, 2017

Study Completion

November 27, 2018

Last Updated

December 27, 2019

Record last verified: 2019-12

Locations

FR(5)