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Adderall XR + TMS for Depression (Stimulant-rTMS Trial)

Phase < 1

Waitlist Available

Led By Scott Wilke, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All subjects will be between the ages of 18-65 and will meet DSM-V criteria for a current episode of major depressive disorder.

Be older than 18 years old

Must not have

Structural cardiac abnormalities

Presence of motor tics or family history of tic disorder

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial looks at the effects of Adderall XR on subjects receiving brain stimulation therapy for Major Depressive Disorder. Subjects will be randomly assigned to an active or placebo group.

Who is the study for?

This trial is for adults aged 18-65 with Major Depressive Disorder who haven't improved after two different antidepressant treatments. They can be on other psychotropic meds, but not psychostimulants or benzodiazepines. Participants must not have certain mental health conditions, substance misuse history, severe physical health issues like heart disease, glaucoma, hyperthyroidism, or metal in the head.

What is being tested?

The study tests if Adderall XR (a stimulant medication) helps brain stimulation therapy work better for depression. Half of the participants will get Adderall and half a placebo pill that does nothing. Everyone gets the same brain stimulation treatment over seven visits including mood assessments.

What are the potential side effects?

Adderall XR may cause nervousness, restlessness, headache, dizziness, fearfulness or anxiety; it might also increase blood pressure and heart rate. The side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old and have been diagnosed with major depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart structure problem.

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I have motor tics or a family history of tic disorders.

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I have had a stroke in the past.

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I have had a brain tumor.

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I have been diagnosed with a major mental health condition that includes psychosis.

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I am currently taking benzodiazepines.

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I have a history of epilepsy or seizures.

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I am currently taking medication for attention or wakefulness.

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A close family member has died suddenly from heart issues.

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I have heart problems like high blood pressure or heart disease.

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I am unable to understand and agree to the study's details.

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I have glaucoma.

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I have an overactive thyroid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks- 6 assessments from baseline to study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks- 6 assessments from baseline to study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks- 6 assessments from baseline to study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Percent Change in Self-rated Inventory of Depressive Symptoms

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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.

0 / 14Eligibility criteria met