Status:
COMPLETED
Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression: OL Cohort
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Schatzberg, Alan, M.D.
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
22-80 years
Phase:
NA
Brief Summary
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In this open label study, all participants ...
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 minutes ove...
Eligibility Criteria
Inclusion
- Male or female, 22 to 80 years of age.
- Able to provide informed consent.
- Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE).
- Participants may currently be on a stable and adequate dose of an antidepressant therapy but the medication must remain stable throughout study enrollment.
- Participants may also have a history of intolerance to antidepressant medications. These patients with the intolerance history will not be required to be currently taking an antidepressant medication.
- Meet the threshold on the total HAMD17 score of \>/=20 at both screening and baseline visits (Day -5/-14 and Day 0).
- Meet the threshold on the total MADRS score of \>/=20 at both screening and baseline visits (Day -5/-14 and Day 0).
- Meet the threshold on the total BDI-II score of \>/=20 at both screening and baseline visits (Day -5/-14 and Day 0).
- In good general health, as ascertained by medical history.
- If female, a status of non-childbearing potential or use of an acceptable form of birth control.
- Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable.
- History of ECT intolerance is permitted.
Exclusion
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- Female that is pregnant or breastfeeding.
- Total HAMD score of \< 20 at the screen or baseline visits.
- Total MADRS score of \< 20 at the screen or baseline visits.
- Total BDI-II score of \< 20 at the screen or baseline visits.
- Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence.
- Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening.
- Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
- Positive screening on the urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
- Current (or chronic) use of opiates.
- History of epilepsy.
- History of shrapnel or metal in the head or skull.
- History of cardiovascular disease or cardiac event.
- History of OCD.
- History of autism spectrum disorder.
- History of rTMS exposure
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03240692
Start Date
May 1 2017
End Date
March 3 2020
Last Update
April 21 2022
Active Locations (1)
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1
Nolan Williams, MD
Palo Alto, California, United States, 94305