Deep Brain Stimulation in Treatment Refractory Depression

NCT01921543 | Terminated Phase 1

• 1 other identifier: s28650
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this trial was to investigate whether patients suffering from treatment refractory- Major Depressive Disorder (MDD) can benefit from DBS (Deep Brain Stimulation) in the brain areas known as inferior thalamic peduncle (ITP) and/or Capsula Interna/Bed nucleus of the stria terminalis (CI/BNST)

Conditions

Major Depressive Disorder

Keywords

Deep Brain Stimulation; Major Depressive Disorder; Psychosurgery; Electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale

  The time frame is an approximation as evaluation is performed after each crossover phase. The time interval between baseline and evaluation depends on the time required for optimisation of DBS parameters.

  up to 14 months

Secondary Outcomes (10)

• Montgomery- Asberg Depression Rating Scale (MADRS)

  up to 14 months

• Inventory for Depressive Symptoms, Self-Report (IDS-SR)

  up to 14 months

• Global measures of illness severity and improvement:the clinician-rated Clinical Global Impressions - Severity (CGI-S) and Clinical Global Impressions - Improvement (CGI-I) scales, and the patient-rated Patient Global Impressions (PGI-S and PGI-I)

  up to 14 months

• Global Assessment of Function (GAF)

  up to 14 months

• patient-rated Symptom CheckList (SCL-90)

  up to 14 months

Study Arms (4)

CI/BNST stimulation on

EXPERIMENTAL

Device: CI/BNST stimulation

CI/BNST vs stimulation off

EXPERIMENTAL

randomized, double blind, 1 week crossover

Device: CI/BNST stimulation; Device: No stimulation

ITP stimulation on

EXPERIMENTAL

Device: ITP Stimulation

CI/BNST vs ITP vs stimulation off

EXPERIMENTAL

randomized, double blind, two month crossover

Device: ITP Stimulation; Device: CI/BNST stimulation; Device: No stimulation

Interventions

ITP Stimulation DEVICE

Model 7428 Kinetra® Neurostimulator Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead Model 3387 DBSTM Brain Lead Model 7482-51 Extension Model 7482-66 Extension Model 7482-95 Extension Model 7436 AccessTM Therapy Controller Model 3628 Dual Screener TM Model 8840 N'Vision

CI/BNST vs ITP vs stimulation off; ITP stimulation on

CI/BNST stimulation DEVICE

Model 7428 Kinetra® Neurostimulator Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead Model 3387 DBSTM Brain Lead Model 7482-51 Extension Model 7482-66 Extension Model 7482-95 Extension Model 7436 AccessTM Therapy Controller Model 3628 Dual Screener TM Model 8840 N'Vision

CI/BNST stimulation on; CI/BNST vs ITP vs stimulation off; CI/BNST vs stimulation off

No stimulation DEVICE

CI/BNST vs ITP vs stimulation off; CI/BNST vs stimulation off

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depressive disorder, severe, unipolar type, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity.
• item Hamilton Depression Rating Scale (HDRS) score of at least 19.
• Global Assessment of Function (GAF) score of 45 or less.
• A recurrent (\>4 episodes) or chronic (episode duration \>2 years) course and a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal ideation or a history of previous suicide attempts or other self-injurious behavior).
• Failure to respond to:
• adequate trials (\>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes AND;
• adequate trials (\>4 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND;
• an adequate trial of Electroconvulsiontherapy (ECT) (\>6 bilateral treatments) AND;
• adequate relapse prevention by antidepressant medication or maintenance ECT or an adequate trial of individual psychotherapy.
• Age ≥18 - ≤65 years.
• Able to comply with the operational and administrative requirements of participation in the study ; able to comply with the questionnaires and the protocol.
• Able to give written informed consent.
• Either drug-free or on a stable drug regimen for at least 6 weeks at the time of entry into the study.
• Good general health.
• Candidates may have undertaken additional trials of potentially beneficial novel combinations of medication and psychotherapy, or they may have undertaken trials of novel interventions lacking definitive evidence of efficacy in severe depression (e.g., light therapy, herbal therapy, transcranial magnetic stimulation, vagal nerve stimulation).

You may not qualify if:

• Current or past non-affective psychotic disorder.
• Any current clinically significant neurological disorder or medical illness affecting brain function.
• Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
• Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation or significant cardiac or other medical risk factors for surgery.
• Current or unstably remitted substance abuse.
• Pregnancy and women of childbearing age not using effective contraception.
• History of severe personality disorder, especially cluster B.
• Imminent risk of suicide (based on the judgment of the investigators)
• Present participation in another clinical trial

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Medtronic: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: August 13, 2013
• Study Start: January 1, 2005
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 16, 2015

Record last verified: 2013-06

Locations

BE (1)