What side effects are associated with this type of intervention?

Common treatments for Bipolar Depression include mood stabilizers like lithium, which can cause side effects such as weight gain, tremors, and thyroid dysfunction. Second-generation antipsychotics, such as risperidone and ziprasidone, may lead to weight gain, metabolic syndrome, and extrapyramidal symptoms. Adjunctive therapies like psychotherapy generally have fewer side effects but require consistent participation. Electroconvulsive therapy (ECT) is another option, particularly for treatment-resistant cases, and can cause short-term memory loss and confusion. Each treatment has a unique side effect profile, and the choice of therapy should be tailored to the individual patient's needs and medical history.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of Bipolar Depression. These include quetiapine (Seroquel), lurasidone (Latuda), and the combination of olanzapine and fluoxetine (Symbyax). These medications are typically used to manage depressive episodes in Bipolar I Disorder. Quetiapine and lurasidone are atypical antipsychotics, while Symbyax combines an antipsychotic with an antidepressant. These treatments aim to stabilize mood and alleviate depressive symptoms, similar to the investigational drug being studied in the clinical trial.

What other types of research exist?

Promising novel alternatives for bipolar depression include: 1) Psilocybin-assisted psychotherapy, which has shown efficacy in treatment-resistant depression. 2) Ketamine, particularly intranasal esketamine, which has demonstrated rapid antidepressant effects. 3) Celecoxib, an anti-inflammatory drug that has shown benefits as an adjunctive treatment. 4) MDMA-assisted psychotherapy, which is being explored for its potential benefits in PTSD and may have applications in mood disorders. These options should be discussed with a healthcare provider to determine suitability based on individual patient needs and medical history.

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Other

Investigational Drug for Bipolar Depression

Verified Trial

Phase 3

Waitlist Available

Research Sponsored by Sumitomo Pharma America, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening.

Subject is 18 to 65 years of age, inclusive, at the time of informed consent.

Timeline

Screening 1 day

Treatment 8 weeks

Follow Up 1 month

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called SEP-4199 CR to see if it can help adults aged 18-65 who have depression from Bipolar I disorder. The study will compare the effects of the medication to see if it reduces symptoms of depression. SEP-4199 has shown antidepressant efficacy in a previous study for bipolar depression.

Who is the study for?

This trial is for adults aged 18-65 with Bipolar I disorder currently experiencing a major depressive episode. They should be in good health, have specific scores on depression and mania rating scales, and not be undergoing treatment for any other primary psychiatric condition.

What is being tested?

The study tests the effectiveness of SEP-4199 CR at two different doses (200 mg and 400 mg) compared to a placebo in treating bipolar depression. Participants will randomly receive either the drug or placebo across various global sites over approximately 10 weeks.

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions associated with antidepressant medications such as nausea, headache, sleep disturbances, weight changes, or mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My current major depressive episode has lasted more than 4 weeks but less than a year.

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I am between 18 and 65 years old.

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My current major depressive episode has lasted more than 4 weeks but less than 12 months.

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I am in good health as confirmed by recent medical exams and tests.

Timeline

Screening ~ 1 day1 visit

Treatment ~ 8 weeks7 visits

Follow Up ~ 1 month1 visit

Screening ~ 1 day

Treatment ~ 8 weeks

Follow Up ~1 month

This trial's timeline: 1 day for screening, 8 weeks for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6

Secondary study objectives

Change From Baseline in Global Severity Assessed by the Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: SEP-4199 CR 400 mgExperimental Treatment1 Intervention

SEP-4199 CR 400 mg/day

Group II: SEP-4199 CR 200 mgExperimental Treatment1 Intervention

SEP-4199 CR 200 mg/day

Group III: PlaceboPlacebo Group1 Intervention

Placebo

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Depression include lithium, lamotrigine, and electroconvulsive therapy (ECT). Lithium works by stabilizing mood and reducing the frequency and severity of mood swings, likely through modulating neurotransmitter activity and neuroprotective effects. Lamotrigine is an anticonvulsant that helps prevent depressive episodes by inhibiting voltage-sensitive sodium channels, which stabilizes neuronal membranes and modulates glutamate release. ECT involves inducing controlled seizures to alter brain chemistry, providing rapid relief from severe depressive symptoms. Understanding these mechanisms is crucial for Bipolar Depression patients as it helps tailor treatment plans to individual needs, ensuring better management of the disorder and improving overall quality of life.

Acetylcholinesterase inhibitors and memantine in bipolar disorder: A systematic review and best evidence synthesis of the efficacy and safety for multiple disease dimensions.A systematic review of the evidence on the treatment of rapid cycling bipolar disorder.