[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07380412":3,"trial-entities:NCT07380412":126,"trial-summary:NCT07380412":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":50,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":82,"eligibility_criteria":83,"std_ages":102,"locations":104,"central_contacts":120,"overall_officials":123,"references":124,"see_also_links":125},"NCT07380412","20764","A Study to Evaluate the Effects of a Supplement on the Side Effects Associated With Stimulant Medications","RECRUITING","2026-03","2026-01","2026-02-02","2025-08-12","Outliers, Inc.","INDUSTRY",false,"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.",null,[18,19,20],"ADHD","Sleep Disturbance","Brain Fog",[18,22],"Anxiety","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},90,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIETARY_SUPPLEMENT","Stasis Daytime and Nighttime","Daytime taken with stimulant medication and food. Nighttime taken 30 minutes before bedtime on an empty stomach.",[36],"Stasis Supplement",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Placebo","Matched placebo product in taste and appearance.",[41],"Placebo Comparator",[43,47],{"measure":44,"description":45,"timeFrame":46},"Change in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdG","Measurement of oxidative stress and cortisol levels will be assessed using the following validated biomarkers:\n\nhs-CRP and serum cortisol from blood samples 8-hydroxy-2'-deoxyguanosine (8-OHdG) from urine samples","Baseline and Month 3",{"measure":48,"description":49,"timeFrame":46},"Change in cortisol levels","Serum cortisol concentration measured via blood draw.",[51,55,58,61,64,67,70,73,76],{"measure":52,"description":53,"timeFrame":54},"Change in sleep quality","Sleep quality assessed via self-report questionnaire.","Baseline, Month 1, Month 2, and Month 3",{"measure":56,"description":57,"timeFrame":54},"Change in irritability","Irritability assessed via self-report questionnaire.",{"measure":59,"description":60,"timeFrame":54},"Change in focus","Focus assessed via self-report questionnaire.",{"measure":62,"description":63,"timeFrame":54},"Change in sociability","Sociability assessed via self-report questionnaire.",{"measure":65,"description":66,"timeFrame":54},"Change in self-reported mood","Mood assessed via self-report questionnaire.",{"measure":68,"description":69,"timeFrame":54},"Change in self-reported stress","Stress levels assessed via self-report questionnaire.",{"measure":71,"description":72,"timeFrame":54},"Change in self-reported appetite","Appetite assessed via self-report questionnaire.",{"measure":74,"description":75,"timeFrame":46},"Change in blood levels of Vitamin C","Serum levels of Vitamin C measured via blood test.",{"measure":77,"description":78,"timeFrame":46},"Change in blood levels of CoQ10","Serum levels of Coenzyme Q10 measured via blood test.","ALL","18 Years","55 Years",true,{"inclusion":84,"exclusion":93,"raw_text":101},[85,86,87,88,89,90,91,92],"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",[94,95,96,97,98,99,100],"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","Inclusion Criteria:\n\n* Aged 18-55 years\n* Currently prescribed stimulant medication for ADHD\n* Experiencing: sleep difficulty, irritability, anxiety, brain fog\n* Stable medication dose ≥3 months\n* Healthy with no uncontrolled chronic conditions\n* Stable on supplements ≥3 months if applicable\n* US resident\n* Willing to maintain current habits\n\nExclusion Criteria:\n\n* Chronic conditions (e.g. cancer, mental illness)\n* Use of psychiatric medications besides stimulants\n* Pregnancy, breastfeeding, thyroid, liver, kidney conditions\n* Recent smokers or heavy alcohol use\n* Night shift workers\n* Participation in other clinical trials\n* Allergies to product ingredients",[103],"ADULT",[105],{"facility":106,"status":7,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":117},"Citruslabs","Las Vegas","Nevada","89118","United States",[112],{"name":113,"role":114,"phone":115,"email":116},"Patrick Renner, MSc","CONTACT","424-245-0284","hello@citruslabs.com",{"lat":118,"lon":119},36.17497,-115.13722,[121],{"name":113,"role":114,"phone":122,"email":116},"4242450284",[],[],[],{"nct_id":4,"conditions":127,"biomarkers":130},[22,128,129],"Attention Deficit Hyperactivity Disorder","Sleep Disorder",[],{"nct_id":4,"found":82,"summary":132,"prompt_version":142},{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is a triple-blind, randomized study comparing two groups (Stasis vs. placebo) and plans to enroll 90 adults.","completed","Stasis Supplement for Stimulant Side Effects in ADHD","This study is looking at whether a dietary supplement called Stasis Daytime and Nighttime can help reduce side effects from stimulant medications used for ADHD. These side effects include sleep difficulties, irritability, anxiety, and brain fog. Researchers will compare Stasis to a placebo (an inactive product that looks and tastes the same) over three months. They will measure changes in levels of oxidative stress and cortisol (a stress hormone) in your body. You might be able to join if you are 18-55 years old, currently take stimulant medication for ADHD, and experience these side effects. You also need to be a US resident and willing to keep your current habits.","Your progress will be monitored for three months, with measurements taken at the beginning and end of this period.",110,"You would take the Stasis Daytime supplement with your stimulant medication and food, and Stasis Nighttime 30 minutes before bed on an empty stomach for three months. Blood tests will be done at the start and after three months.","Not stated in the trial record.",[33,38],"v2"]