Varenicline for Manic Disorder

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Pacific Treatment & Research Center at UCSD, La Jolla, CA
Manic Disorder+7 More
Varenicline - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a lower dose of varenicline may be more effective for individuals with bipolar disorder, schizophrenia or schizoaffective disorder.

See full description

Eligible Conditions

  • Manic Disorder
  • Schizoaffective Disorders
  • Nicotine Dependence
  • Schizophrenia

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Varenicline will improve 1 primary outcome and 1 secondary outcome in patients with Manic Disorder. Measurement will happen over the course of Through completion of study, an average of 2 years.

Year 2
Explore whether nicotine metabolism influences medication tolerability
Feasibility of combining ACT with 2 different varenicline-assisted quitting strategies

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Varenicline
Abnormal/Vivid Dreams
17%
Asthma flare
17%
Dry Mouth
17%
Nausea/Vomiting
17%
Dizziness/Lightheadedness
17%
Constipation
17%
Fatigue
0%
Insomnia/Trouble Sleeping
0%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04089982) in the Varenicline ARM group. Side effects include: Abnormal/Vivid Dreams with 17%, Asthma flare with 17%, Dry Mouth with 17%, Nausea/Vomiting with 17%, Dizziness/Lightheadedness with 17%.

Trial Design

2 Treatment Groups

Standard Dose Varenicline
1 of 2
Low Dose Varenicline
1 of 2
Active Control
Experimental Treatment

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Varenicline is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Low Dose Varenicline
Drug
0.5 mg twice daily with 0.5 mg daily titration over one full week
Standard Dose Varenicline
Drug
1.0 mg twice daily with standard titration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through completion of study, an average of 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through completion of study, an average of 2 years for reporting.

Who is running the study

Principal Investigator
R. A.
Robert Anthenelli, MD
University of California, San Diego

Closest Location

Pacific Treatment & Research Center at UCSD - La Jolla, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, or with an Axis I diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder People who have a diagnosis of bipolar disorder or schizophrenia spectrum disorder from a DSM-V, or a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder from Axis I, are considered to be outpatients. show original
If you smoke at least 10 cigarettes per day and have an expired carbon monoxide (CO) breathalyzer of ≥ 10 ppm at screening and baseline visits, you are eligible for this study. show original
who understands your culture It is important to have access to a mental health provider who understands your culture show original
You are in the age group of 18-70 years. show original
Many smokers are motivated to quit smoking, but often find it difficult to do so show original

Patient Q&A Section

What is manic disorder?

"Manic disorder is a mental disorder that consists of a single manic episode plus at least two episodes (or persistent mood symptoms) for a minimum of seven days or greater, separated by at least 28 days without depressive symptoms. Although not all single episodes of mania are manic, some mood disorders such as bipolar disorder and mood dysregulated by medication are diagnosed as mania.\n" - Anonymous Online Contributor

Unverified Answer

Can manic disorder be cured?

"Treating MDA is difficult. Nevertheless, some MDA patients respond to treatment, and these respond equally to antidepressant, antipsychotic, or tricyclic antidepressant treatment. The effectiveness of the MDA treatment will depend on factors such as the duration and severity of the episodes and the initial response to the treatment." - Anonymous Online Contributor

Unverified Answer

What causes manic disorder?

"More than half of first-onset manic disorders are attributable to the medication or substance use. Many of the underlying mechanisms are unknown and the exact etiology of many of the first-onset manic disorders is unknown. Identifying the underlying cause of mania will be a key step in elucidating the cause of manic disorder." - Anonymous Online Contributor

Unverified Answer

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

"The lifetime prevalence of unipolar and bipolar II disorders in the United States is higher than previously estimated. Men have a higher rate of unipolar and bipolar II disorders than do women, and bipolar II disorder is significantly less common, although more severe, in women." - Anonymous Online Contributor

Unverified Answer

What are common treatments for manic disorder?

"Manic disorder can occur in children to young adults and can occur with or without a psychotic episode in between attacks. Treatment can include antidepressants, mood stabilisers or valproate. Treatment is highly dependent on the course of the disorder and on the response of the patient to the treatments. It is imperative that patients understand the long term consequences of their treatment and treatment should be maintained if possible." - Anonymous Online Contributor

Unverified Answer

What are the signs of manic disorder?

"This answer: In a recent study, findings, we found that depressive episodes are common in out-patients with bipolar disorder. In the initial phase, the manic feature is less salient than a marked increase in depressive symptoms, or worsening mental status. However, by the third depressive episode, the symptoms resemble features of a mania or hypomania (except for the increased speed of speech, which may be more apparent in depressive episodes than in\nmany depressive features). Bipolar\ndisorder is an illness that can be associated with many syndromes." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating manic disorder?

"The authors concluded that the mood-stabilizing drugs lithium and valproate showed a high rate of efficacy as part of an initial mood-stabilizing regimen when monotherapy or adjunct therapy was begun. A few patients benefited from a prolonged mood stabilizer therapy of lamotrigine, valproate, or topiramate alone or in combination with each other. There is emerging data supporting the efficacy of lamotrigine and topiramate with or without valproate as a treatment for bipolar disorder. In the long term, there is no convincing evidence that atypical (non-medication) psychodynamic or psychosocial interventions are any more efficacious than mood stabilizers." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of varenicline?

"This audit did not disclose any severe or life-threatening adverse events during 12 months of treatment with varenicline. Side effects were prevalent but few in number, and most were mild and transient. Most side effects were reported on the patients' self-report, and patients may have exaggerated or under-reported their symptomatology. The majority of adverse events reported by patients were mild or transient although some patients may have continued to use the product despite their symptoms. Given the common adverse events that may present as the first indication of a potential adverse effect, careful documentation and a regular review of symptomatology are essential." - Anonymous Online Contributor

Unverified Answer

How does varenicline work?

"These data are consistent with a direct action of varenicline upon dopamine-releasing neurons. These data also suggest that a direct interaction between varenicline and α7-nAChRs might not be involved in its antidepressant effects." - Anonymous Online Contributor

Unverified Answer

Does varenicline improve quality of life for those with manic disorder?

"Treatment with varenicline is well tolerated. Its effectiveness for patients with MD is encouraging and adds to the evidence base for this medication in manic disorder." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets manic disorder?

"People with manic disorder tend to have a higher average age in which they experience a manic episode. Future studies examining the age of onset should further characterize this relationship." - Anonymous Online Contributor

Unverified Answer

What does varenicline usually treat?

"Varenicline may not be an effective therapy for PDM. A substantial subset of patients with PDM are not likely to benefit from treatment with varenicline." - Anonymous Online Contributor

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