Early Psychosis study: Cannabidiol oral solution
Official title Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis
ClinicalTrials.gov ID: NCT04411225
What this study is testing
What is Cannabidiol oral solution?
an investigational oral solution being studied as an add‑on treatment for early psychosis
Also referred to as CBD.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding cannabidiol (CBD) to usual care helps early psychosis symptoms and thinking.
- Who it's for
- You may be able to join if you are a teenager or adult who has early psychosis.
- What's involved
- You would take a liquid CBD solution or a pretend treatment for 8 weeks while staying on your regular medicines. You would visit the clinic for check‑ins and simple tests.
- Time commitment
- The study lasts about 8 weeks with regular clinic visits.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 30
You may be able to join if
- Clinically stable and in a nonacute phase of their illness for at least 2 months, First episode psychosis participants will have been maintained on...
- Exhibit no more than moderate levels of positive symptoms (defined by ratings of ≤ 4) on PANSS items P1 (delusions), P2 (conceptual disorganization)...
- No more than a minimal level of depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia (CDSS)
- Acceptable diagnoses will include APS, Psychosis NOS, Schizophreniform, Schizophrenia, and Schizoaffective per the Structured Clinical Interview for...
You likely can't join if
- Concomitant medical or neurological illness;
- Significant head injury;
- Impaired intellectual functioning IQ\ 85 suggesting higher premorbid IQ.
- High suicidal risk assessed by the The Columbia-Suicide Severity Rating Scale (C-SSRS)42
- Pregnant women and those who do not agree to avoid becoming pregnant
- Patients requiring treatment with Azelastine, Azelastine; Fluticasone, Dronabinol, Valproic Acid, or Divalproex Sodium
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.