ADHD, Brain Fog, Sleep Disturbance
Conditions
Keywords
ADHD, Anxiety
Brief summary
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
Daytime taken with stimulant medication and food. Nighttime taken 30 minutes before bedtime on an empty stomach.
Matched placebo product in taste and appearance.
Sponsors
Study design
Masking description
Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdG | Baseline and Month 3 | Measurement of oxidative stress and cortisol levels will be assessed using the following validated biomarkers: hs-CRP and serum cortisol from blood samples 8-hydroxy-2'-deoxyguanosine (8-OHdG) from urine samples |
| Change in cortisol levels | Baseline and Month 3 | Serum cortisol concentration measured via blood draw. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep quality | Baseline, Month 1, Month 2, and Month 3 | Sleep quality assessed via self-report questionnaire. |
| Change in irritability | Baseline, Month 1, Month 2, and Month 3 | Irritability assessed via self-report questionnaire. |
| Change in focus | Baseline, Month 1, Month 2, and Month 3 | Focus assessed via self-report questionnaire. |
| Change in sociability | Baseline, Month 1, Month 2, and Month 3 | Sociability assessed via self-report questionnaire. |
| Change in self-reported mood | Baseline, Month 1, Month 2, and Month 3 | Mood assessed via self-report questionnaire. |
| Change in self-reported stress | Baseline, Month 1, Month 2, and Month 3 | Stress levels assessed via self-report questionnaire. |
| Change in self-reported appetite | Baseline, Month 1, Month 2, and Month 3 | Appetite assessed via self-report questionnaire. |
| Change in blood levels of Vitamin C | Baseline and Month 3 | Serum levels of Vitamin C measured via blood test. |
| Change in blood levels of CoQ10 | Baseline and Month 3 | Serum levels of Coenzyme Q10 measured via blood test. |
Countries
United States