What side effects are associated with this type of intervention?

Common treatments for mania include mood stabilizers like lithium and valproate, antipsychotics such as olanzapine and quetiapine, and light therapy. Mood stabilizers can cause side effects like weight gain, tremors, and gastrointestinal issues. Antipsychotics may lead to weight gain, metabolic syndrome, and extrapyramidal symptoms. Light therapy, while generally well-tolerated, can sometimes cause eye strain, headaches, and sleep disturbances if not properly timed. Blue-blocking glasses, a non-pharmacological option, have minimal side effects but may cause mild discomfort or visual disturbances initially.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of mania, particularly focusing on mood stabilizers and antipsychotics. Lithium, a mood stabilizer, has long been used to treat manic episodes. Second-generation antipsychotics such as quetiapine, aripiprazole, and olanzapine have also been approved for managing mania. These medications help regulate mood and can indirectly influence sleep patterns, which is crucial for managing manic symptoms. While blue-blocking glasses are a novel approach targeting the circadian rhythm directly, traditional pharmacological treatments primarily focus on mood stabilization and symptom control.

What other types of research exist?

Promising novel alternatives to blue-blocking glasses for treating mania in 2024 include: 1) Long-acting injectable second-generation antipsychotics such as risperidone and aripiprazole, which may offer a safe and effective alternative to oral medications. 2) Neuromodulation procedures like subcallosal cingulate deep brain stimulation and bilateral anterior capsulotomy, which have shown clinical improvements in treatment-resistant cases. These options provide new avenues for managing manic symptoms and regulating the sleep-wake cycle.

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Blue-Blocking Sunglasses for Mania (OSAN Trial)

N/A

Recruiting

Led By Jess G Fiedorowicz, MD, PhD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

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

Must have

Participants must be able to read and understand English or French

Be 18 to 70 years of age

Must not have

Have severe eye disease or trauma

Have sleep apnea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up inferred from melatonin/cortisol curves, rest-activity cycle (wrist actigraphy), heart rate/temperature monitoring, electroencephalography

Awards & highlights

Summary

This trial tests special glasses that block blue light to help hospitalized patients with mania. By blocking blue light, the glasses help regulate the brain's internal clock and improve sleep patterns, which can reduce manic symptoms. This could offer a low-cost, non-medication treatment option for those suffering from mania.

Who is the study for?

This trial is for adults aged 18-70 with manic symptoms from bipolar disorder, who can understand English or French and give informed consent. It's not for those with severe eye issues, traumatic brain injury, sleep apnea, or taking melatonin supplements.

What is being tested?

The study tests if wearing blue-blocking glasses can help manage mania by mimicking dark therapy effects without the impracticality of staying in a dark room. Participants will be randomly given either blue-blocking glasses or lightly-tinted glasses to compare outcomes.

What are the potential side effects?

Since this treatment involves non-invasive blue-blocking glasses, there are no direct medical side effects like those associated with medications. However, individual comfort levels with wearing the glasses may vary.

Eligibility Criteria

Inclusion Criteria

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

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I can read and understand English or French.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe eye condition or injury.

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I have sleep apnea.

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I am currently taking melatonin supplements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; week one; two week (end of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; week one; two week (end of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week one; two week (end of study) 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 in the Young Mania Rating Scale

Secondary study objectives

Amount of antipsychotic (in chlorpromazine equivalents) and benzodiazepine used (in lorazepam equivalents)

Change Circadian Rhythms

Change in Altman Self-Rating Mania Scale - 5-Item Self Rating Mania Scale (ASRM)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Blue-blocking glassesExperimental Treatment1 Intervention

Participants will wear orange/amber colored lenses that filter wavelengths of light in the blue spectrum while awake from 6 p.m. to 8 a.m.

Group II: Lightly-tinted glassesPlacebo Group1 Intervention

This control will involve glasses that selectively filter short wavelength (e.g., ultraviolet), but not visible blue light during the same time window. Participants will wear these glasses while awake from 6 p.m. to 8 a.m.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blue-blocking glasses

2021

N/A

~140

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 mania often target the regulation of neurotransmitters and the stabilization of mood. For instance, lithium and anticonvulsants like lamotrigine work by modulating neurotransmitter activity and stabilizing neuronal excitability. Atypical antipsychotics such as risperidone and olanzapine act on dopamine and serotonin receptors to balance mood and reduce manic symptoms. Treatments like blue-blocking glasses, which regulate the sleep-wake cycle by blocking blue light, help stabilize circadian rhythms. This is crucial for mania patients as disrupted sleep-wake cycles can exacerbate manic episodes. By improving sleep patterns and reducing overstimulation, these treatments help manage the intensity and frequency of manic symptoms.

Light therapy in patients with rapid cycling bipolar disorder: preliminary results.Efficacy of melatonin as an adjunct in the treatment of acute mania: a double-blind and placebo-controlled trial.Emerging experimental therapeutics for bipolar disorder: clues from the molecular pathophysiology.