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Recruiting NCT07380412

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

No phase Interventional ADHD Sleep Disturbance Brain Fog

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stasis Daytime and Nighttime, Placebo.
Who it may be relevant to
Registry conditions: ADHD, Sleep Disturbance, Brain Fog. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement Stasis Daytime and Nighttime
    Daytime taken with stimulant medication and food. Nighttime taken 30 minutes before bedtime on an empty stomach.
  • Dietary supplement Placebo
    Matched placebo product in taste and appearance.

Primary outcome measures

  • Change in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdG [Time frame: Baseline and Month 3]
  • Change in cortisol levels [Time frame: Baseline and Month 3]
Secondary outcome measures (9)
  • Change in sleep quality [Time frame: Baseline, Month 1, Month 2, and Month 3]
  • Change in irritability [Time frame: Baseline, Month 1, Month 2, and Month 3]
  • Change in focus [Time frame: Baseline, Month 1, Month 2, and Month 3]
  • Change in sociability [Time frame: Baseline, Month 1, Month 2, and Month 3]
  • Change in self-reported mood [Time frame: Baseline, Month 1, Month 2, and Month 3]
  • Change in self-reported stress [Time frame: Baseline, Month 1, Month 2, and Month 3]
  • Change in self-reported appetite [Time frame: Baseline, Month 1, Month 2, and Month 3]
  • Change in blood levels of Vitamin C [Time frame: Baseline and Month 3]
  • Change in blood levels of CoQ10 [Time frame: Baseline and Month 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Citruslabs — Las Vegas

Identifiers

NCT: NCT07380412 · 20764

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗