Post-acute Infectious Syndrome - Aripiprazole Symptom Evaluation (PAIS-AriSE)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChristiana Franke
About this trial
Post-acute infectious syndrome (PAIS), including post-COVID-19 condition (PCC or Long COVID), can develop after an infection and may cause persistent symptoms such as fatigue, problems with memory and concentration ("brain fog"), mood changes, and reduced quality of life. In some people, these symptoms continue for months or longer and can substantially affect daily activities. Currently, there are no approved treatments that specifically target these symptoms.
Aripiprazole is a medicine that is approved to treat certain psychiatric disorders. At low doses, it may affect brain signaling and immune processes that are thought to contribute to symptoms experienced by people with PAIS. Small observational studies have suggested that low-dose aripiprazole may improve symptoms such as fatigue and cognitive impairment in people with related conditions, but its effectiveness and safety have not yet been confirmed in a randomized controlled trial.
The purpose of this study is to evaluate whether low-dose aripiprazole is safe and more effective than placebo in improving fatigue and other neuropsychiatric symptoms in adults with PAIS.
This is a phase 2b, randomized, double-blind, placebo-controlled crossover trial. Approximately 138 participants with PAIS will be enrolled. Participants will be randomly assigned to one of two treatment sequences. One group will receive low-dose aripiprazole for 8 weeks followed by placebo for 8 weeks. The other group will receive placebo first, followed by low-dose aripiprazole. The two treatment periods will be separated by a 2-week washout period. Neither the participants nor the study team will know which treatment is being given during each treatment period.
The primary objective is to determine whether low-dose aripiprazole improves fatigue after the first 8-week treatment period compared with placebo. Fatigue will be assessed using the Chalder Fatigue Questionnaire. Secondary objectives include evaluating the effects of treatment on physical functioning, quality of life, memory and cognitive performance, mood, post-exertional malaise, illness-related anxiety and distress, and fatigue in participants who meet diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Safety will be assessed throughout the study by monitoring adverse events.
The results of this study may help determine whether low-dose aripiprazole is a safe and effective treatment option for people with PAIS
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male, female or diverse adult who is 18 years or older at the time of informed consent
Potential participant is willing, understanding and able to provide informed consent
Signed informed consent prior to initiation of any trial-related measure
History of confirmed or suspected (PCR or serology or rapid antigen detection, certificate of attending physician, sick note) infectious disease
Disqualifiers
Prior chronic neuroimmunological or neurodegenerative disease
Severe psychiatric disease (psychosis, bipolar disorder, severe major depression with inpatient treatment) within the last 10 years
Current malignant disease (including space-occupying brain tumors)
Concomitant antipsychotic medication
Trial design
Design model
Crossover
Treatments tested in this trial
Aripiprazole (low-dose, 1mg)
DrugThe treatment period consists of two consecutive 8-week periods of blinded IMP administration: 8 weeks of aripiprazole followed by 8 weeks of placebo (Sequence A), or 8 weeks of placebo followed by 8 weeks of aripiprazole (Sequence B). Follow-up assessments will be conducted after each treatment period, at Weeks 9 and 19 of the study.
Placebo
DrugThe treatment period consists of two consecutive 8-week periods of blinded IMP administration: 8 weeks of active comparator followed by 8 weeks of placebo (Sequence A), or 8 weeks of placebo followed by 8 weeks of active comparator (Sequence B).
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Aripiprazole (low-dose, 1mg)Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intra-patient change in the Chalder Fatigue Scale (CFQ) by ≥ 3 points from baseline to week 9 in patients with PAIS.
The CFQ assesses the extent and severity of fatigue and has been used in multiple randomized controlled trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is rated on a 4-point scale, resulting in a total score ranging from 0 (no symptoms) to 33 (maximum symptom severity). In this trial, intra-patient change in CFQ by ≥3 points from baseline to week 9 will be interpreted as meaningful improvement.
Time frame
9 weeks after first IMP intakeSecondary outcomes
1
Intra-patient change in CFQ by ≥3 points from baseline to week 9 in the subgroup fulfilling ME/CFS criteria.
@Studyteam: Please add a description of how the ME/CFS subgroup is defined in this trial.
Time frame
9 weeks after first IMP intake2
Intra-patient change in CFQ from baseline to week 19 and from week 9 to week 19.
The within-patient change in physical and mental fatigue, as measured by the CFQ, will be assessed from baseline to week 19 and from week 9 to week 19.
Time frame
9 and 19 weeks after first IMP intake3
Intra-patient change in the Fatigue Severity Score (FSS) from baseline to week 9 and to week 19 and from week 9 to week 19.
The FSS is a 9-item scale that assesses fatigue severity and its impact on a person's activities and lifestyle. Each item is rated on a 7-point scale (1 = strongly disagree; 7 = strongly agree), resulting in a total score ranging from 9 (no fatigue) to 63 (severe fatigue). The within-patient change in fatigue severity will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.
Time frame
9 and 19 weeks after first IMP intake4
Intra-patient change in the Bell Disability Scale from baseline to week 9 and to week 19 and from week 9 to week 19
The Bell Disability Scale is a standard assessment tool used to evaluate functional ability in adults with ME/CFS. It comprises 11 statements describing the patient's functional status, including symptom severity at rest and during activity, overall activity level, and the ability to work, travel, and perform self-care activities. Scores range from 0 (bedridden) to 100 (no symptoms and fully functional). The within-patient change in functional ability will be assessed from baseline to week 9, from baseline to week 19, and from week 9 to week 19.
Time frame
9 and 19 weeks after first IMP intakeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christiana Franke
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: