Trials / Unknown
UnknownNCT01801319
A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression (TRD). A total of 40 eligible participants will be randomized to four treatment sequences (10 participants per sequence). Each participant will be treated over a 6-month period with active or sham stimulation in which both the participants and the attending psychiatrists will be blinded to treatment allocation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Libra Deep Brain Stimulation System |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2017-06-01
- Completion
- 2017-12-01
- First posted
- 2013-02-28
- Last updated
- 2017-04-26
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01801319. Inclusion in this directory is not an endorsement.