Bipolar Disorder Trial, Recruiting NCT03829787 Sponsor: University Hospitals Cleveland Medical Center Condition: Bipolar Disorder
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Bipolar Disorder Trial, Recruiting

NCT03829787
Recruiting Not Applicable

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:

This trial has five separate groups. People may be considered for one group depending on their situation:

Group 1 – Bipolar disorder without current anxiety or substance use disorder:

  • Adults aged 18 or older of any gender
  • People who have been diagnosed with bipolar I or II disorder (confirmed using a standard psychiatric interview)
  • People who are currently in a depressive episode or in a period of remission from a mood episode
  • People whose mania symptoms score at or below a low threshold on a standard rating scale (confirmed by the trial site)
  • People who the investigator considers able to understand and follow the study requirements
  • People who the investigator considers capable of giving informed consent
  • People who are consistently taking their prescribed psychiatric medications as directed by their doctor

Group 2 – Bipolar disorder with a current anxiety disorder (generalised anxiety disorder, panic disorder, and/or social phobia):

  • Adults aged 18 or older of any gender
  • People who have been diagnosed with bipolar I or II disorder (confirmed using a standard psychiatric interview)
  • People who are currently in a depressive episode or in a period of remission from a mood episode
  • People who currently have a diagnosis of generalised anxiety disorder, panic disorder, and/or social phobia (confirmed using a standard psychiatric interview)
  • People whose anxiety symptoms score at or above a certain level on a standard rating scale (confirm with trial site)
  • People whose mania symptoms score at or below a low threshold on a standard rating scale (confirmed by the trial site)
  • People who the investigator considers able to understand and follow the study requirements
  • People who the investigator considers capable of giving informed consent
  • People who are consistently taking their prescribed psychiatric medications as directed by their doctor

Group 3 – Bipolar disorder with a current anxiety disorder and a current substance use disorder:

  • Adults aged 18 or older of any gender
  • People who have been diagnosed with bipolar I or II disorder (confirmed using a standard psychiatric interview)
  • People who meet the criteria for a substance use disorder within the last 3 months (confirm with trial site)
  • People who currently have a diagnosis of generalised anxiety disorder, panic disorder, and/or social phobia (confirmed using a standard psychiatric interview)
  • People who are currently in a depressive episode or in a period of remission from a mood episode
  • People whose anxiety symptoms score at or above a certain level on a standard rating scale (confirm with trial site)
  • People whose mania symptoms score at or below a low threshold on a standard rating scale (confirmed by the trial site)
  • People who the investigator considers able to understand and follow the study requirements
  • People who the investigator considers capable of giving informed consent
  • People who are consistently taking their prescribed psychiatric medications as directed by their doctor

Group 4 – Bipolar disorder without an anxiety disorder but with a current substance use disorder:

  • Adults aged 18 or older of any gender
  • People who have been diagnosed with bipolar I or II disorder (confirmed using a standard psychiatric interview)
  • People who meet the criteria for a substance use disorder within the last 3 months (confirm with trial site)
  • People who are currently in a depressive episode or in a period of remission from a mood episode
  • People whose mania symptoms score at or below a low threshold on a standard rating scale (confirmed by the trial site)
  • People whose anxiety symptoms score at or below a low threshold on a standard rating scale (confirm with trial site)
  • People who the investigator considers able to understand and follow the study requirements
  • People who the investigator considers capable of giving informed consent
  • People who are consistently taking their prescribed psychiatric medications as directed by their doctor

Group 5 – Healthy volunteers:

  • Adults aged 18 or older of any gender
  • People who the investigator considers able to understand and follow the study requirements
  • People who the investigator considers capable of giving informed consent
  • People who are in good physical health as determined by the research psychiatrist
  • People who have never had and do not currently have any psychiatric disorder (confirmed using a standard psychiatric interview)

Who may not be able to join:

The following apply across the relevant groups — the trial site will determine which apply to each group:

  • People who have a significant structural problem in the brain, such as damage from a stroke, bleeding, a tumour, or multiple sclerosis
  • People who have a progressive neurological disease, such as a condition that causes the brain or nervous system to gradually deteriorate
  • People who are currently pregnant or planning to become pregnant
  • People who test positive for illegal drugs or prescription medications they do not have a valid prescription for (applies to Groups 1, 2, and 5)
  • People who are currently taking steroids, stimulants, or opioid-based pain medications (applies to Groups 1, 2, and 5)
  • People who meet the criteria for an alcohol or drug use disorder within the last 6 months, excluding caffeine use (applies to Groups 1 and 2)
  • People who are currently experiencing nicotine dependence, or who have smoked cigarettes or used any other nicotine-containing products within one week before the eye-tracking part of the study
  • People who have had electroconvulsive therapy (ECT) — a type of brain stimulation treatment — within the last 6 months
  • People who are currently intoxicated or going through acute withdrawal from a substance (applies to Groups 3 and 4)
  • People who have a current or lifetime diagnosis of obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder (ADHD) (applies to Groups 2, 3, and 4, with some variation — confirm with trial site)
  • People who have been assessed as meeting the criteria for antisocial personality disorder or borderline personality disorder (applies to Groups 2, 3, and 4)
  • People who have any current psychiatric disorder other than a current depressive episode, including anxiety disorders, substance use disorders, antisocial personality disorder, or borderline personality disorder (applies to Group 1)
  • People who have any psychiatric disorder, including severe personality disorders (applies to Group 5)
  • People who have a current anxiety disorder or ADHD (applies to Group 4)

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 8 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Keming Gao, MD, PhD, University Hospitals Cleveland Medical Center

Phone: 216/844-2862

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University Hospitals Cleveland Medical Center
Registry
ClinicalTrials.gov
Start date
27 March 2019
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Measure the differences in attentional bias among the 5 groups by assessing how long it takes a subject to locate and fixate on each face on the screen; Measure the differences in reward sensitivity among the 5 groups by assessing the amplitude of the saccade to reward and non-reward stimuli; Measure the differences in reward sensitivity among the 5 groups by assessing the velocity of the saccade to reward and non-reward stimuli; Measure the differences in cognitive control among the 5 groups by assessing the amplitude of the antisaccade; Measure the differences in cognitive control among the...

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: 8 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