A Pilot Study of Deep Brain Stimulation for Treatment Resistant Major Depressio

Phase 1

Completed

• Conditions: Mental Health - Depression; Treatment resistant major depression

• Registration Number: ACTRN12611000889954
• Lead Sponsor: Monash Alfred Psychiatry Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-19
• Study Completion: 2013-06-03
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Have a DSM-IV diagnosis of a major depressive episode as confirmed by both SCID interview and independent psychiatrist review (X2)

2. Age 18-70

3. Have treatment resistant depression at Stage V of the Thase and Rush classification. This is a very strict definition of TRD and requires failure to respond to adequate courses of at least several different classes of antidepressants and a course of bilateral ECT.

4. Have a Montgomery-Asberg Depression Rating Scale score of > 25 (moderate – severe depression)

5. Demonstration of capacity to give informed consent: this will need to be assessed and documented by two independent psychiatrists and signing of the consent form will take place in the presence of an independent consent monitor. Consent capacity will also be reviewed by the Victorian Psychosurgery Review Board.

Exclusion Criteria

1. Have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating

2. Immediate suicide risk

3. Significant concurrent axis 1 or 11 psychiatric morbidity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: change in severity of depressive symptoms, defined as:<br><br>Montgomery Asberg Depression Rating Scale<br>50% reduction = clinical response<br><8 = clinical remission[Timepoint: baseline, post implantation / pre-stimulation onset, six months post stimulation onset, one year post stimulation onset.]

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome 1: cognition as measured via standardised neuropsychology tasks.<br><br>- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; Versions A & B)<br><br>- Controlled Oral Word Association Test (FAS/CFL)<br><br>- Trail Making Test (A & B)<br><br>- Golden Stroop Test <br><br>- Letter Number Sequencing subtest (WAIS?III)[Timepoint: baseline, one year post stimulation onset];Secondary Outcome 2: Quality of life as measured via the Quality of Life Enjoyment and Satisfaction Scale: Short Form[Timepoint: baseline, post implantation / pre-stimulation onset, six months post stimulation onset, one year post stimulation onset.];Secondary Outcome 3: Social functioning as measured via the Social Adaptation Self-Evaluation Scale[Timepoint: baseline, post implantation / pre-stimulation onset, six months post stimulation onset, one year post stimulation onset.]