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CBD oil studied as a treatment for severe behavioral issues in kids with intellectual disability

NCT ID NCT04821856

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether cannabidiol (CBD) oil can reduce severe behavioral problems in children aged 6-18 with intellectual disability. 132 participants received either CBD or a placebo for 8 weeks. The main goal was to see if CBD improves irritability and other challenging behaviors, as measured by a parent questionnaire.

What this could mean

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

Active substance
cannabidiol (CBD) oil
What this could lead to
If it works, this could provide a new treatment option for severe behavioral problems in children with intellectual disability.
What could go wrong
This is a phase 2 trial with a moderate size (132 participants). The results may not be strong enough to confirm effectiveness, and CBD may cause side effects or interact with other medications.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

132 people

The number who actually took part.

Started

May 2021

Finished

Aug 2025

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

6 to 18 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. Males and females aged 6 - 18 years of age; 2. DSM-5 diagnosis of intellectual disability (ID): 1. Full scale IQ \< 70 on standardized cognitive assessment. Testing results must be sighted by the investigators and performed within two years of enrollment. In the event that records of prior testing are unavailable or the assessment was more than 2 years prior, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence-II. 2. Deficit in adaptive function (basis for severity rating of ID in DSM-5) in at least one activity of life on the Vineland Adaptive Behavior Scales (derives scores in Communication, Daily Living Skills and Socialization domains, and a Global Adaptive score). If records of prior testing are unavailable or the assessment was more than 2 years prior, this will be completed by the parent or guardian. 3. SBP: Defined as scores of: 1. 18 or higher on the Aberrant Behavior Checklist-Irritability subscale (ABC-I), and 2. moderate or higher on the Clinical Global Impressions-Severity scale; 4. No changes in either medication or other interventions in the 4 weeks prior to randomization, and intention to remain on same dose for the duration of the study; 5. Written informed consent from parent or legal guardian; 6. Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator. Exclusion Criteria: 1. Non-English speaking parents; 2. Psychosis; 3. Taking clobazam, mTOR inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day.; 4. Abnormal liver function tests: defined as ALT \> twice ULN; 5. Abnormal renal function tests: defined as creatinine \> ULN 6. Current use of medicinal cannabis, or use in the 4 weeks prior to screening; 7. Pregnant or intending to become pregnant during the study, or breastfeeding; 8. Known allergy to cannabidiol or cannabis products

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Monash Children's Hospital

    Clayton, Victoria, 3168, Australia

  • Royal Children's Hospital / Murdoch Children's Research Institute

    Parkville, Victoria, 3052, Australia

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

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