Treatment for Manic Disorder

Phase-Based Estimates
1
Effectiveness
1
Safety
Western Psychiatric Hospital, Pittsburgh, PA
Manic Disorder
Eligibility
< 65
All Sexes
Eligible conditions
Manic Disorder

Study Summary

This study is evaluating whether a therapy delivered via telehealth can help reduce symptoms of bipolar disorder in youth.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 3 primary outcomes, 4 secondary outcomes, and 1 other outcome in patients with Manic Disorder. Measurement will happen over the course of 18 months.

18 months
Exploratory: Association between actigraphy and passive sensing-derived measures of sleep-wake
Rate of Subthreshold Manic Symptoms
Risk for Subthreshold Manic Episodes
Severity of Affective lability
Sleep variability (objective)
Sleep variability (subjective)
Total sleep time (Objective)
Total sleep time (subjective)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Healthy Lifestyle Intervention (HL)

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Healthy Lifestyle Intervention (HL)
Behavioral
HL is based on the treatment manual developed in a prior trial for adults and adolescents with BP. HL includes psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health. In HL, patients are taught to develop and maintain an individualized lifestyle plan and provided support and encouragement for making progress toward their goals. HL clinicians will deliver 8 sessions over 6 months via secure telehealth platform.
Interpersonal and Social Rhythm Therapy (IPSRT)
Behavioral
Interpersonal and Social Rhythm Therapy (IPSRT) for at-risk offspring includes 8 sessions over 6 months delivered via secure telemedicine platform. The basis of the intervention is the treatment manual iteratively developed and tested in close consultation with content experts during our open pilot study and R34.The intervention focuses on education about BP risk, stabilizing sleep and daily routines and interpersonal relationships.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18 months for reporting.

Who is running the study

Principal Investigator
T. R. G.
Prof. Tina R Goldstein, Associate Professor
University of Pittsburgh

Closest Location

Western Psychiatric Hospital - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
should be considered for long-term lithium treatment If you are a parent with a diagnosis of bipolar I or II, you should be considered for long-term lithium treatment. show original
A person with a Baseline Risk Calculator score of more than 0.05 is considered at risk for developing a heart attack within the next 10 years. show original
Age 12-18 years
Able/willing to give informed consent/assent

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes manic disorder?

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The genetic basis of the illness is incompletely understood. One suggestion is that there may be a complex interaction between genetic and environmental factors. This hypothesis is supported by a [series of studies that found that the prevalence of manic disorder is significantly increased in first-degree relatives of persons with bipolar mania]. Results from a recent paper may reflect the genetic contribution of both MDD as well as BPD.

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Can manic disorder be cured?

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A large proportion of patients with a diagnosis of either schizophrenia or mania can recover (with or without medication) from those conditions on their own spontaneously. However, with the correct diagnosis and the proper treatment, patients may recover from manic mania. The possibility that treatment may influence this is considered.

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What are the signs of manic disorder?

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There are many signs of manic disorder such as grandiosity, increased activity, and an abnormally rapid speech rate. All of these manifestations are associated with decreased levels of dopamine in the brain, resulting in the development of hypomanic symptoms such as grandiosity and hyperactivity. Other signs of mania include extreme irritability and disordered sleep.

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How many people get manic disorder a year in the United States?

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Around 80,000 people are diagnosed with mania, making it the third most common mental disorder. Approximately 11% of the total U.S. population has bipolar I personality disorder.

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What is manic disorder?

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There are two major groups of people who are affected by mania: those affected by a major depressive disorder and those with bipolar I disorder and then those that are not affected by mania.

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What are common treatments for manic disorder?

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There is still no consensus on the optimal treatment for manic episode, but several trials are running in the USA and around the world. Treatment options for these conditions include a variety of agents, including antidepressants and mood stabilizers. The mood stabilizers have clearly proven to be helpful in the management of manic episode. They are often more effective than antidepressants, and seem to lead to a significant and sustained reduction not only of manic symptoms, but also that of manic episodes in general. The efficacy of these agents is related to specific pharmacokinetic factors. More investigations are necessary to gain a better understanding of the treatment of manic disorder.

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Who should consider clinical trials for manic disorder?

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Manic disorder has a long tradition in the treatment of the mentally ill, but there are few clinical trials specifically targeting the treatment of this disorder until recently. Those trials that exist generally report little to no evidence of effectiveness with large differences in patient counts in the study comparisons. Although it is important to consider the complexity of bipolar disorder and take into account clinical presentation, age, and gender, it seems that there is hardly a viable treatment for this disorder, which requires the careful adjustment of several parameters in order to improve the response and the efficacy of the treatment.

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What is treatment?

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Currently [clozapine has been approved by FDA (https://www.medicalnews.com/health/mental-health/article/clozapine-gets-label-for-bipolar-disorder) and EU (EC)for treatment of bipolar disorder and treatment-resistant mania] in both Europe (EUREDIS) and United States (FDA) has not yet received approval for other depression treatment. Some people use these drugs as add-on with antidepressants or [SSRI] to manage their depression. Given FDA approval for bipolar disorder, clozapine, risperidone, and paliperidone should not receive approval for treatment-resistance depression.

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What is the latest research for manic disorder?

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The literature discusses clinical and management approaches to patients with manic disorder, and provides information on treatment options, especially when medication treatment has had little or no effect, or has triggered intolerable side-effects. The literature provides clues to management in a number of situations: schizophrenia, bipolar disorder, and substance use disorder. However, due to variability in terminology, it is hard to draw on the literature and compare studies.

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What is the primary cause of manic disorder?

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We propose that mania arises as a consequence of an imbalance between a nsnoring of the hypothalamic-pituitary-adrenal axis (HPA axis) and a nlack of dopaminergic control. Our hypothesis is based on a\ndifficulty of the HPA axis in the presence of psychotic symptoms and on a\ndevelopmental imbalance between the left and right prefrontal cortex during childhood which may result in\na loss of inhibitory control of the frontal lobes. We suggest that psychostimulants are used to alleviate the anxiety\nand irritability associated with an imbalance of the HPA.

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Have there been any new discoveries for treating manic disorder?

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In the last two decades, there has been a lot of new research aimed at treating mood disorders due to the fact that they are a major burden on society and are a challenge to treat. This is why it is important to try and find a better treatment. There are several new treatments that are being tested now and some of them might be very useful in treating mood disorders. There is a new medication that is being tested in bipolar disorder called ramelteon that may be used as a treatment as well as another medication called divalproex sodium which is being tested to see it's effectiveness in bipolar disorder.

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