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Compares treatment options for Early Psychosis
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?
Cannabidiol oral solution is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for early psychosis.
Also referred to as Placebo.
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 is an outpatient, single center, between-group, double blind, placebo controlled design. Approximately 120 adolescents and adult patients will be randomized to either have their treatment augmented with Cannabidiol Oral Solution (CBD) or with a matching CBD placebo for 8 weeks.
- 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
- First episode psychosis (onset within the last 2 years) or attenuated psychosis syndrome (APS), stabilized with treatment for at least 8 weeks prior...
- 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's taking place
- 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 - 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?
Study sites include La Jolla, California, United States; San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.