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

NCT04509102 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: 20-000050
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Major Depressive Disorder

Keywords

MDD, Randomized, rTMS; Randomized; rTMS

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change in Self-rated Inventory of Depressive Symptoms

  Mean percent change in Self-rated Inventory of Depressive Symptoms assessment scores for subjects, compared between placebo and Adderall XR groups. The 30 item Inventory of Depressive Symptomatology (IDS) (Rush et al. 1986, 1996) assess the severity of depressive symptoms. It is a 30 -item questionnaire with scores ranging from 0-3 per time. Minimum and maximum values are 0 and 84, respectively. Higher score indicates a worsening in depressive symptoms and a lower score indicated an improvement in depressive symptoms.

  up to 4 weeks- 6 assessments from baseline to study completion

Study Arms (2)

Active

ACTIVE COMPARATOR

Subjects randomized to Adderall will take an tablet/capsule by mouth daily.

Drug: Adderall-XR

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Adderall-XR DRUG

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

Active

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

SLI381

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Scott Wilke, MD

  UCLA Semel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Only the biostatistician conducting the randomization will know each participant's treatment condition (Adderall XR versus placebo) for the duration of the trial. Participants, psychiatrists, and technicians delivering rTMS and collecting assessments will be blinded to treatment condition (Adderall XR versus placebo). Active medication will be over-encapsulated by the UCLA Research Pharmacy to appear identical to placebo capsules. At the conclusion of all treatments, participants will be asked whether they believe they received Adderall XR release versus placebo. The blind will then be broken and participants may elect to continue medication management at the discretion of their personal psychiatrist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: i. Prior to initiation of any study activities, participants will be randomly assigned to one of two treatment conditions: Adderall XR (n=15) versus placebo (n=15). Randomization will be completed by a biostatistician from the UCLA Clinical and translational science institute (CTSI) statistics core, who will generate the randomization list with stratification and provide this list to the UCLA pharmacy.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: August 11, 2020
• Study Start: September 27, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)