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Investigation of the potential beneficial effects of cannabidiol in the treatment of tardive dyskinesia

Investigation of the potential beneficial effects of cannabidiol in the management of oral-lingual-buccal dyskinesias using animal studies and a clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14688109
Enrollment
60
Registered
2015-05-07
Start date
2015-12-01
Completion date
Unknown
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tardive dyskinesia Nervous System Diseases Drug-induced dystonia

Interventions

1. Group 1 has high cannabidiol extract Nabidiolex® (CBD) (300mg) administered twice a day for six weeks as an adjunctive treatment alongside their usual antipsychotic medication. CBD will be administ

Sponsors

Stellenbosch University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults 18 years and older 2. Currently meets the ICD-10 diagnosis of a psychotic disorder, verified with the Mini International Neuropsychiatric Interview (MINI-PLUS) questionnaire. 3. Currently meets the clinical diagnosis of tardive dyskinesia confirmed with the Abnormal Involuntary Movement Scale (AIMS) 4. Patients should currently be receiving treatment for a psychotic disorder and should be on either the atypical or conventional antipsychotics 5. Patient gives informed consent

Exclusion criteria

Exclusion criteria: 1. ICD-10 diagnosis of an organic mental illness, substance misuse disorder or a seizure disorder 2. Serious or chronic physical illness 3. Known severe drug allergies or hypersensitivity to CBD

Design outcomes

Primary

MeasureTime frame
Improvement in symptoms of tardive dyskinesia measured using the Abnormal Involuntary Movement Scale (AIMS). Assessments will be conducted at baseline, 2 weeks, 4 weeks, 6 weeks (post-treatment) and at 12 weeks follow-up.

Secondary

MeasureTime frame
1. Side effects of CBD will be periodically assessed with the Glasgow check list and reported at each assessment 2. Improvement in psychotic symptoms

Countries

Nigeria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026