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Old drug, new hope: spironolactone may help kids with rare Autism-Linked gene mutations

NCT ID NCT06678685

Disease control Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether spironolactone, a common diuretic, can improve learning and behavior in children aged 3–10 with NCOR gene mutations, which are linked to autism spectrum disorder. Only 2 children will be enrolled, and researchers will measure changes in intelligence and autism symptoms. The drug is already used safely in children for other conditions, but this is an early exploratory trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spironolactone
What this could lead to
If it works, this could point toward a treatment for learning and memory problems in children with certain NCOR gene mutations.
What could go wrong
This is a very small, early-stage trial with only 2 children, so results may not apply broadly. Spironolactone is generally safe but can affect potassium levels and blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 2 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ADOS-2 diagnostic criteria for autistic children 2. Patients with NCOR related gene mutation detected by whole exon test; 3. Age: 3-10 years old; 4. The subject and (or) guardian sign the informed consent, agreeing that the researcher will cooperate with the clinical trial process and collect clinical data and peripheral blood and urine samples; Exclusion Criteria: 1. have other pathogenic mutations (confidence higher than the NCOR related mutation); 2. Boys over 10 years old; 3. Allergic to spironolactone, used spironolactone one month before enrollment; 4. Hyperkalemia, serum potassium concentration \> 5.5mmol/L; 5. Renal insufficiency; 6. Used related drugs one month before enrollment: potassium supplement, angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, digoxin, coletenamine, acetylsalicylic acid, abiraterone; 7. Fever (body temperature above 37.3°); 8. Clinically significant metabolic, hematological, liver, immune, urological, endocrine, neurological, pulmonary, psychiatric, skin, allergic, renal, or other major conditions in the determination of ASD that may affect the interpretation of study findings or patient safety.

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Conditions

The condition(s) this trial relates to.

atrial septal defect autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ASD Ncor gene mutations Spironolactone

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

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