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ENROLLING BY INVITATION

NCT04509102

EARLY_PHASE1

Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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 active or placebo group. Active group will be asked to take one 15 mg pill once daily of Adderall XR (amphetamine) and the Placebo group will be asked take an identical appearing tablet/capsule, one tablet by mouth daily. The placebo tablet has no active ingredients and has no affect on the body or mind. With the exception of the study drug, all other study activities between both groups will be identical. Subjects will use the assigned study drug two weeks before therapy and throughout the first 10 therapy treatments. A total of seven(7) visits will be required for screening, drug assignment, and completion of mood assessments. This study will enroll a total of 30 Subjects.

Official title: *Full Title of the Submission: Psychostimulant Augmentation of Repetitive TMS (rTMS) for the Treatment of Major Depressive Disorder: A Randomized, Placebo-controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-09-27

Completion Date

2027-12-01

Last Updated

2026-02-03

Healthy Volunteers

Conditions

Major Depressive Disorder

Interventions

DRUG

Adderall-XR

Subjects randomized to Adderall XR will initiate treatment with 15 mg daily (one 15 mg tablet each morning) for 21 days.

DRUG

Placebo

Subjects randomized to placebo will take an identical-appearing tablet/capsule and, in order to maintain blinding, will also take one tablet by mouth daily. The placebo substance will be sugar for 21 days.

Inclusion Criteria: * 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 Criteria: * 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

Locations (1)

UCLA Semel

Los Angeles, California, United States