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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT04509102
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 27, 2021
Status verified
Jan 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active
    Subjects randomized to Adderall will take an tablet/capsule by mouth daily.
  • Placebo Comparator: 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.

Primary Outcome Measure

Mean Percent Change in Self-rated Inventory of Depressive Symptoms [ Time Frame: up to 4 weeks- 6 assessments from baseline to study completion ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA SemelLos AngelesCalifornia90025-

Find similar trials in Los Angeles, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
UCLA Semel· Los Angeles, CA

Related Studies