Status:
ENROLLING_BY_INVITATION
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
Lead Sponsor:
University of California, Los Angeles
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This study analyzes the affects or Adderall extended-release (XR) in Subjects receiving brain stimulation therapy for the treatment of Major Depressive Disorder. Subjects will be assigned by chance to...
Detailed Description
This study aims to recruit 30 subjects between the ages of 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for a current episode of major depressive disorder....
Eligibility Criteria
Inclusion
- All subjects will be between the ages of 18-65 and will meet DSM-V criteria for a current episode of major depressive disorder.
- Meet criteria for treatment resistance as defined by lack of response to two prior antidepressant trials at adequate dosage and duration. Participants may use any psychotropic medications other than psychostimulants or benzodiazepines, and may continue these medications during the study.
- The outside treating psychiatrist must agree that enrollment in the study is safe and acceptable for the subject.
Exclusion
- Inability to give informed consent
- Lifetime diagnosis of bipolar affective disorder
- Lifetime diagnosis of major depressive disorder with psychotic features, schizophrenia, schizoaffective disorder, or any other psychotic disorder
- History of psychotic symptoms
- Lifetime diagnosis of substance use disorder
- History of stimulant misuse or abuse
- Active substance abuse
- Anxiety, tension, or agitation that is of sufficient severity to make it difficult for the subjects to tolerate psychostimulants and/or 10 Hz rTMS treatment
- Current use of psychostimulant medication
- Current use of benzodiazepines
- Current use of an Monoamine oxidase inhibitors (MAOI) or use of an MAOI within the past two weeks
- History of hypersensitivity to Adderall XR
- History of intolerance of any psychostimulant medication
- Pregnancy, breastfeeding, or plans to become pregnant during the study period
- Glaucoma
- Presence of motor tics or family history of tic disorder
- Symptomatic cardiovascular disease including hypertension, coronary artery disease, arteriosclerosis, cardiomyopathy, or arrhythmia
- Hyperthyroidism
- Structural cardiac abnormalities
- Family history of sudden cardiac death in a first degree relative
- History of epilepsy or seizure
- History of stroke
- History of brain tumor
- Presence of any metal in the head
- Presence of pacemaker or medical devices implanted close to the site of magnetic stimulation
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04509102
Start Date
September 27 2021
End Date
December 1 2027
Last Update
December 20 2024
Active Locations (1)
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1
UCLA Semel
Los Angeles, California, United States, 90025