A Study to Evaluate the Effects of a Supplement on the Side Effects Associated With Stimulant Medications

Outliers, Inc.

Status: Enrolling

Conditions: Sleep Disturbance; ADHD; Brain Fog

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Stasis Daytime and Nighttime

Study type: Interventional

Funder types: Industry

Identifiers

NCT07380412

20764

Details and patient eligibility

About

This is a hybrid, two-arm, triple-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of the Stasis supplement on reducing oxidative stress, cortisol levels, and side effects associated with stimulant medications used for ADHD over a three-month period in adults.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 18-55 years
• Currently prescribed stimulant medication for ADHD
• Experiencing: sleep difficulty, irritability, anxiety, brain fog
• Stable medication dose ≥3 months
• Healthy with no uncontrolled chronic conditions
• Stable on supplements ≥3 months if applicable
• US resident
• Willing to maintain current habits

Exclusion criteria

• Chronic conditions (e.g. cancer, mental illness)
• Use of psychiatric medications besides stimulants
• Pregnancy, breastfeeding, thyroid, liver, kidney conditions
• Recent smokers or heavy alcohol use
• Night shift workers
• Participation in other clinical trials
• Allergies to product ingredients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Stasis Supplement

Experimental group

Treatment:

Dietary Supplement: Stasis Daytime and Nighttime

Placebo Comparator

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo