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25 Bipolar Disorder Trials near Dallas, TX
Power is an online platform that helps thousands of Bipolar Disorder patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerProbiotics for Bipolar Disorder
Dallas, Texas
This trial tests if taking capsules with good bacteria can help people who were hospitalized for severe mood episodes avoid being hospitalized again. The capsules aim to improve gut health, which might reduce body inflammation and help with mental health. The study will also look at changes in mood, psychiatric symptoms, and cognitive abilities.
Stay on current meds
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:HIV, Neurological Disorder, Substance Use, Others
66 Participants Needed
ABBV-932 for Bipolar Disorder
Dallas, Texas
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder.
ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide.
Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Details
Trial Status:Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
160 Participants Needed
Multiple Medications for Bipolar Depression
Dallas, Texas
This trial is testing four different medications to find the best treatment for adults with bipolar disorder type 1 who are currently depressed. The medications work by balancing brain chemicals that affect mood. The goal is to help patients recover from depression and stay well.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Manic Episode, Schizophrenia, Substance Use, Others
Must Not Be Taking:Study Medications
2726 Participants Needed
Clozapine vs Risperidone for Psychosis
Dallas, Texas
The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, \~50% each) in order to enroll n=320 (B1 and B2) into the RCT.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Substance Abuse, Neurological Conditions, Others
Must Be Taking:Antipsychotics
524 Participants Needed
Cariprazine for Pediatric Schizophrenia
Dallas, Texas
This trial is testing the safety and effectiveness of cariprazine in children and teens with schizophrenia, bipolar I disorder, or autism. The goal is to see if the medication is safe and beneficial for use in these young patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Major Depressive, Schizoaffective, Intellectual Disability, Others
310 Participants Needed
VNS for Bipolar Depression
Dallas, Texas
This trial is testing whether VNS Therapy, which sends electrical impulses to the vagus nerve, can reduce depression symptoms in patients who haven't responded to other treatments. The study will observe the effects of VNS therapy over a year. Vagus nerve stimulation (VNS) is a recognized treatment for severe treatment-resistant depression and has shown promising results.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Schizophrenia, Bipolar, Dementia, Others
6800 Participants Needed
KarXT for Bipolar Disorder
Irving, Texas
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)
The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Suicidal Behavior, Rapid Cycling, Substance Use, Others
300 Participants Needed
KarXT for Mania
Irving, Texas
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Suicidal Risk, Others
Must Not Be Taking:Psychotropics
274 Participants Needed
Cariprazine for Bipolar Disorder in Youth
Dallas, Texas
This trial is testing the safety and effectiveness of Cariprazine for treating depressive episodes in children and teenagers with bipolar I disorder. The goal is to find out if Cariprazine can help young people with this condition. Cariprazine is an atypical antipsychotic recently approved for the treatment of depressive episodes in adults with bipolar I disorder.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Substance Disorder, Seizures, Others
Must Not Be Taking:Psychotropics, CYP3A4 Inhibitors
380 Participants Needed
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
450 Participants Needed
KarXT for Bipolar Disorder
DeSoto, Texas
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:BP-II, Major Depression, Substance Use, Others
Must Not Be Taking:Psychotropics
274 Participants Needed
RAP-219 for Bipolar Disorder
Richardson, Texas
This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Schizoaffective, Substance Use, Others
224 Participants Needed
BHV-7000 for Bipolar Disorder
Richardson, Texas
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Medical Condition, Adherence Issues, Risk To Self/others
200 Participants Needed
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Acute Intoxication, Suicide Risk, Others
Must Not Be Taking:Benzodiazepines, Hypnotics, Antipsychotics
140 Participants Needed
KarXT for Bipolar Disorder
Richardson, Texas
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
Stay on current meds
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Suicidal Risk, Others
Must Be Taking:Lithium, Valproate, Lamotrigine
424 Participants Needed
OLZ/SAM for Schizophrenia
DeSoto, Texas
This trial evaluates the safety and tolerability of OLZ/SAM in children and adolescents with schizophrenia or Bipolar I disorder. OLZ/SAM combines olanzapine to manage symptoms and samidorphan to reduce weight gain. Olanzapine is a well-established antipsychotic effective for schizophrenia and bipolar I disorder, but its use is limited by significant weight gain; samidorphan is added to mitigate this side effect.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Suicide Risk, Pregnancy, Others
Must Be Taking:OLZ/SAM
236 Participants Needed
Iloperidone Safety for Adolescent Schizophrenia
DeSoto, Texas
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:12 - 17
Key Eligibility Criteria
Disqualifiers:Others
Must Not Be Taking:Investigational Drugs, Drugs Of Abuse
100 Participants Needed
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Not Listed
220 Participants Needed
BHV-7000 for Bipolar Disorder
Richardson, Texas
The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
256 Participants Needed
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Suicidal Risk, Catatonia, Psychotic Features, Others
Must Be Taking:Psychostimulants
500 Participants Needed
Why Other Patients Applied
"I have struggled living with bipolar disorder for nearly 20 years. I am always hopeful to find new treatments or medications that might really help my symptoms, and I feel strongly pulled to help contribute to bipolar research/science any way that I can. Finally use this brain for some good! :)"
PC
Bipolar Disorder PatientAge: 40
"I have tried many different drugs in the past. I just want to find something that works. I just want to be happy and content with life. I'm always having "episodes" where I just shut down and cry and get mad. I need to find a drug that helps me live a happier life. I have everything I ever wanted, yet still can't stay happy. Hopefully this trial helps me and other people in these situations. "
QE
Bipolar Disorder PatientAge: 35
"I've been experiencing bipolar depression since I was a teenager and have tried many treatments that have not helped: SSRIs (Prozac), Wellbutrin, talk therapy. None worked. I've heard great things about ketamine therapy and would really like to try it. I'd like to access it through a clinical trial."
FM
Bipolar Disorder PatientAge: 38
"My mania is under control but I still have no way of handling depression. I've been looking into new treatments and I would be so grateful to be able to try one of the latest research treatments. Even if it fails: it's worth a shot, better than giving up. I'm a bit at wit's end."
PW
Bipolar Disorder PatientAge: 30
"Over 20 years, I've tried 6+ antidepressants and anti-anxiety meds to no avail. Cymbalta is the ONLY one that has ever made a difference (which I can use because I have bipolar 2, not 1) but it had some other side effects. I've been hesitant to try any trials, but also at a deadend of any relief. So, let's give it a shot."
ZJ
Bipolar Disorder PatientAge: 42
Lumateperone for Bipolar Mania
Richardson, Texas
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Dementia, Substance Use, Others
350 Participants Needed
Lumateperone for Bipolar Mania
DeSoto, Texas
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Dementia, Substance Use, Others
350 Participants Needed
Lumateperone for Pediatric Bipolar Depression
Flower Mound, Texas
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Intellectual Disability, Suicidal Risk, Others
384 Participants Needed
Ketamine for Bipolar Depression and Suicidal Thoughts
Fort Worth, Texas
This trial tests a treatment that starts with a ketamine injection to quickly reduce severe depression and suicidal thoughts, followed by maintenance pills. It targets patients with severe bipolar depression who need rapid symptom relief. Ketamine rapidly alters brain activity, and the pills help maintain these positive changes. Ketamine has shown effectiveness as a rapid-acting antidepressant with antisuicidal effects, but evidence for long-term maintenance therapy is limited.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
150 Participants Needed
NRX-101 for Bipolar Depression
Fort Worth, Texas
This trial tests a two-step treatment for adults with severe bipolar depression and suicidal thoughts. It starts with a quick-acting ketamine dose followed by an oral medication to maintain improvement. The goal is to see if this approach is better than using lurasidone alone. Ketamine has been shown to rapidly reduce depressive and suicidal symptoms in both unipolar and bipolar depression.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
72 Participants Needed
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