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Column | Value |
---|---|
Trial registration number | NCT05597722 |
Full text link
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : May 30, 2023, 3:29 p.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : May 30, 2023, 3:29 p.m. Source : ClinicalTrials.gov |
Not reported |
Registration date
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
2022-10-28 |
Recruitment status
Last imported at : May 30, 2023, 3:29 p.m. Source : ClinicalTrials.gov |
Terminated |
Study design
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
Long covid |
Inclusion criteria
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
inclusion criteria: history of sars-cov-2 infection as defined as a positive pcr or home antigen test patients with long-covid as defined as covid symptoms that persist for three months or longer. between the ages of 21 and 65 moderate cognitive impairment (moca score to meet criteria is < or =18) present for at least 3 months response of "no" to the screening question, "are you pregnant or do you plan to become pregnant in the next 3 months?" access to a smartphone |
Exclusion criteria
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
history of dementia, psychosis, mania, addiction or current conditions requiring immediate hospitalization previous adverse or allergic reaction to adderall or other amphetamines pre-existing cardiac or kidney condition, severe hypertension, glaucoma, advanced arteriosclerosis, hyperthyroidism, and taking an maoi within the past 14 days current or past substance misuse previous use of rxwell (completed 3 or more techniques) current use of amphetamine-dextroamphetamine history of uncontrolled blood pressure subjects taking methylphenidate; lisdexamfetamine; non-adderall amphetamine products; atomoxetine; viloxazine; modafinil; armodafinil; nortriptyline and other tricyclic drugs; bupropion; tramadol; and monoamine oxidase inhibitor (maoi) drugs (including linezolid). inability to pay for study medication. |
Number of arms
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
Eva Szigethy |
Inclusion age min
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
21 |
Inclusion age max
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
65 |
Countries
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
United States |
Type of patients
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
Severity scale
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : May 30, 2023, 3:29 p.m. Source : ClinicalTrials.gov |
7 |
primary outcome
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
Change in Cognitive Impairment - BrainCheck;Change in Cognitive Impairment - ImPACT;Change in Cognitive Impairment - MOCA |
Notes
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
Phase 4 |
Arms
Last imported at : Nov. 23, 2022, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2653, "treatment_name": "Amphetamine-dextroamphetamine", "treatment_type": "Csf", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2652, "treatment_name": "Digital cognitive behavioral intervention", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}] |