Phase 3 Depression and Anxiety Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- A parent or legal guardian must give written consent, and the patient themselves must also agree in writing to take part
- Boys or girls between 10 and 17 years old (inclusive)
- Has been formally diagnosed with bipolar I or bipolar II disorder and is currently going through a depressive episode (without psychosis), confirmed by a structured medical interview
- Has had at least one episode of mania or hypomania at some point in their life
- The current depressive episode has lasted at least 4 weeks but less than 12 months
- Scores at or above a certain level on a standardized depression rating scale at both the screening and baseline visits (confirm with trial site)
- Scores at or below a certain level on a mania rating scale at both the screening and baseline visits, showing that mania symptoms are not currently severe (confirm with trial site)
Who may not be able to join:
- Has a primary mental health diagnosis other than bipolar I or bipolar II disorder — though ADHD is an exception, as long as any ADHD medication has been at a stable dose for at least 30 days before screening and is expected to stay stable throughout the study
- Has an intellectual disability, as determined by the study doctor
- Has been hospitalized for a manic episode within the 30 days before being enrolled in the study
- Shows a significant improvement (25% or more) in depression scores between the screening and baseline visits, or depression scores fall below the required level at baseline
- Is considered by the study doctor to be at significant risk of suicidal behavior during the study
- Reported certain levels of suicidal thoughts in the 6 months before screening, or since the screening visit (confirm with trial site)
- Has made one or more suicide attempts in the 2 years before screening
- Scores above a certain level on the suicidal ideation question of the depression rating scale at screening or baseline (confirm with trial site)
- Is considered to be in immediate danger of harming themselves or others
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Phone: 844-434-4210
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Children's Depression Rating Scale-Revised (CDRS-R)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.