NCT07714213Not yet recruitingPhase 2
Post-acute Infectious Syndrome - Aripiprazole Symptom Evaluation (PAIS-AriSE)
Prospective, Randomized, Double-blind, Placebo-controlled Phase 2a Trial of Low-dose Aripiprazole in Patients With Neuropsychiatric Impairment in Post-acute Infectious Syndrome (PAIS) Including Post-COVID-19 Condition (PCC)
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 15 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 15 May 2028
- Lead sponsor
- Christiana Franke
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT07714213
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 138
- From 1 Oct 2026 to the primary completion date, 15 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chronic neuroimmunological or neurodegenerative disease
- Concomitant antipsychotic medication
- Participation in another interventional clinical trial within the last 3 months or within five half-lives of the investigational product (whichever is longer)
Other illness
- 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)
- Patient is allergic or has contraindication to Aripiprazole or lactulose and cellulose
- Other conditions that are likely to affect the safety of the study treatment (e.g. severely impaired immune status)
Other
- Patient is pregnant or breastfeeding
- WOCBP who are unwilling to use an effective method of contraception as defined in inclusion criterion above
- Bell disability scale \< 30
- Patient is institutionalized by order of court or public authority
- Patient who might be dependent on the sponsor, the investigator or the trial site
- Place of living does not allow the potential participant to attend the planned study visits
Who the study is looking for
- 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
- Ongoing symptoms of PAIS/PCC for ≥ 3 months
- Self-reported neuropsychiatric symptoms at screening
- For women of childbearing potential (WOCBP):
- Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
- If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before randomization, and practicing a highly effective birth control method (failure rate of less than 1%)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.