What side effects are associated with this type of intervention?

Common treatments for depression that increase neural responses to reward and feelings of alertness and well-being include stimulants like methylphenidate and certain antidepressants such as SSRIs (Selective Serotonin Reuptake Inhibitors). Stimulants can cause side effects such as insomnia, increased heart rate, anxiety, and potential for abuse. SSRIs, while generally well-tolerated, can lead to side effects including nausea, headache, sexual dysfunction, and increased risk of suicidal thoughts, particularly in young adults. Both types of treatments require careful monitoring by healthcare providers to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of depression that enhance neural responses to reward and improve alertness and well-being. Psychostimulants such as methylphenidate and modafinil are known to improve mood and cognitive function in patients with depression, particularly in palliative care settings. Additionally, SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) are commonly prescribed to increase serotonin and norepinephrine levels, which can enhance mood and alertness. These treatments are supported by evidence demonstrating their efficacy in improving depressive symptoms in patients with physical illnesses, including those with life-threatening conditions.

What other types of research exist?

Promising novel alternatives to Methamphetamine for depression treatment in 2024 include: 1) Stimulation of the subgenual cingulate gyrus (SCG), 2) MDMA-assisted psychotherapy, 3) Repetitive transcranial magnetic stimulation (rTMS), and 4) Modafinil.

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Other

Methamphetamine Impact on Brain Function in Healthy Subjects (DEG Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT), work by altering neural responses and neurotransmitter levels in the brain. SSRIs increase serotonin levels, which can enhance mood and emotional stability. CBT helps patients reframe negative thought patterns, thereby improving emotional responses. These treatments matter for depression patients because they target the underlying neural mechanisms that contribute to depressive symptoms, aiming to restore balance and improve overall well-being. Similar to methamphetamine, which increases neural responses to reward and feelings of alertness, these treatments seek to enhance positive neural activity and mood regulation.

Phase < 1

Waitlist Available

Led By Harriet de Wit

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: day 1(baseline), 3

Summary

This trial is testing how methamphetamine affects brain activity and feelings of reward in healthy young adults. The study uses brain scans to see how the drug changes brain activity and how these changes relate to feelings of pleasure and alertness. Methamphetamine is a highly addictive stimulant that affects emotional and cognitive behavior through its potent dopaminergic properties.

Who is the study for?

This trial is for healthy adults who consume less than 4 alcoholic or caffeinated drinks daily and have a BMI between 19-26. It's not for those on regular medication, with high blood pressure, pregnant women, anyone trying to conceive, people with a history of stimulant drug dependence or current mental health disorders.

What is being tested?

The study tests the effects of Methamphetamine (MA) on brain reward function using EEG. Participants will take MA at two different doses and a placebo in three sessions while doing tasks related to reward anticipation and inhibition control.

What are the potential side effects?

Methamphetamine may cause increased feelings of alertness and well-being but can also lead to side effects like rapid heart rate, elevated blood pressure, euphoria, potential addiction risk, and negative mood changes after it wears off.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: day 1(baseline), 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: day 1(baseline), 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: day 1(baseline), 3 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).

Side effects data

From 2021 Phase 1 trial • 8 Patients • NCT04178993

50%

Elevated Heart Rate

50%

Elevated Blood Pressure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Comparator: Placebo

Active Comparator: Duloxetine (60 mg)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo Then MethamphetamineExperimental Treatment2 Interventions

Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 20 mg methamphetamine.

Group II: Methamphetamine Then PlaceboExperimental Treatment2 Interventions

Participants first receive 20 mg methamphetamine at their first session in the laboratory Then will return to the laboratory 72 hours later and will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Methamphetamine

2013

Completed Phase 1

~260

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT), work by altering neural responses and neurotransmitter levels in the brain. SSRIs increase serotonin levels, which can enhance mood and emotional stability. CBT helps patients reframe negative thought patterns, thereby improving emotional responses. These treatments matter for depression patients because they target the underlying neural mechanisms that contribute to depressive symptoms, aiming to restore balance and improve overall well-being. Similar to methamphetamine, which increases neural responses to reward and feelings of alertness, these treatments seek to enhance positive neural activity and mood regulation.

Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?