Modafinil and Cognitive Function in POTS
Key facts
- Who runs it
- Vanderbilt University Medical Center
- Where
- Nashville, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- Phase
- Early phase 1
- People taking part
- 20 people enrolled
- Started
- Oct 2014
- Expected to end
- Dec 2026
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- Modafinil
- Propranolol
- Record updated
- 15 January 2026
Who can take part
- Age
- 18 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Males and females of all races between the ages of 18 to 60 years
- Diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center based on the following consensus criteria:(a) an increase in heart rate ≥ 30 beats per minute within 10 minutes of changing from the supine to standing position; (b) absence of orthostatic hypotension (defined as a decrease in systolic blood pressure ≥ 20 mmHg or diastolic blood pressure ≥ 10 mmHg upon standing); and (c) chronic symptoms (≥ 6 months) consistent with POTS that are worse with standing and are relieved by lying down
- Able and willing to provide informed consent
Who cannot take part
- Patients taking serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors
- Other factors which in the investigator's opinion would prevent the subject from completing the study protocol such as poor compliance during previous studies
- Known allergies or contraindications to study medications
- Overt causes for POTS such as acute dehydration and bed rest deconditioning
- Pregnancy or breast-feeding
- Inability to give or withdraw informed consent
- Asthma (due to the contraindication of propranolol for asthma patients)
Where in United States
- Vanderbilt UniversityNashville, United StatesNo longer taking part
About the trial
What the trial wants to find out
A common complaint among patients with Postural Tachycardia Syndrome (POTS) is "brain fog" or difficulty concentrating. This problem is poorly understood.
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The purpose of this study is to better understand the cognitive dysfunction associated POTS, and to determine optimal treatment strategies for this condition. In this study, the investigators will test the hypothesis that acute administration of the psychostimulant drug modafinil can improve seated measures of cognitive function in patients with POTS.
The 4 groups in the trial
- PlaceboPlacebo, for comparison
Patients will receive two inactive placebo pills filled with microcrystalline cellulose on a randomized study day. Medications will be dummy blinded to the patient and investigators.
- ModafinilTreatment being tested
Patients will receive single doses of modafinil (200 mg, oral) and placebo on a randomized study day. Medications will be dummy blinded to the patient and investigators.
Treatment: Placebo and Modafinil
- PropranololTreatment being tested
Patients will receive single doses of propranolol (20 mg, oral) and placebo on a randomized study day. Medications will be dummy blinded to the patient and investigators.
Treatment: Placebo and Propranolol
- Modafinil plus PropranololTreatment being tested
Patients will receive single doses of modafinil (200 mg, oral) and propranolol (20 mg, oral) on a randomized study day. Medications will be dummy blinded to the patient and investigators.
Treatment: Modafinil and Propranolol
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Modafinil and Cognitive Function in Postural Tachycardia Syndrome
- Record updated
- 15 January 2026