Phase 4 Bipolar Disorder Trial, Recruiting NCT04580134 Sponsor: University of Texas Southwestern Medical Center Condition: Bipolar Disorder
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Phase 4 Bipolar Disorder Trial, Recruiting

NCT04580134
Recruiting Phase 4

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:

  • You are between 18 and 60 years old
  • You are any gender, race, or ethnicity
  • You are able to read, speak, and understand English
  • You are in a stable condition medically
  • You have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features (based on a structured clinical interview)
  • Your symptoms are at a moderate-to-severe level, as measured by a standard psychiatric rating scale called the PANSS (confirm with trial site)
  • Your blood test shows a normal level of a type of white blood cell called neutrophils (confirm with trial site)

Who may not be able to join:

  • You have a low estimated level of reading ability or intellectual functioning based on a standardized test (confirm with trial site)
  • You have had problems with alcohol or drug abuse in the past month, or drug dependence in the past 3 months
  • You have a neurological condition such as seizures, stroke, or a serious brain injury where you lost consciousness for 30 minutes or more
  • You have a serious medical condition such as severe heart disease or AIDS that may affect brain function
  • You are taking certain medications that affect brain wave activity or interact with the study drugs, and cannot safely stop taking them (confirm with trial site)
  • You are pregnant, breastfeeding, or currently in prison or another institution
  • You are unwilling to use reliable contraception during the trial
  • You have a history of a severe reaction to antipsychotic medications called neuroleptic malignant syndrome
  • You have previously been treated with clozapine, or have recently received certain long-acting injectable antipsychotic medications
  • You have had intolerable side effects to, or a previous failed treatment with, either clozapine or risperidone
  • You have had a serious allergic drug reaction involving your skin and internal organs (sometimes called DRESS or DIHS)
  • You are considered at high risk for suicide — for example, you have made more than one attempt in the past 12 months that needed medical attention, any attempt in the past 3 months, or you currently have a plan and intent to end your life
  • You currently have thoughts of harming someone else with a plan and intent to act on them

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 29 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Carol Tamminga, M.D., University of Texas Southwestern Medical Center

Phone: 214-648-5276

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

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 March 2022
Est. completion
30 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in the PANSS total score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov