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3-(3-Methanesulfonyl-Phenyl)-1-Propyl-Piperidine Hydrochloride

This article discusses two clinical trials investigating the use of OSU6162, also known as 3-(3-Methanesulfonyl-Phenyl)-1-Propyl-Piperidine Hydrochloride, in treating depression and bipolar disorder. The first trial examines OSU6162 as an add-on treatment for patients with depression resistant to SSRI/SNRI medications, while the second trial explores its potential efficacy in treating bipolar depression. These studies aim to evaluate the drug’s effectiveness, safety, and tolerability in addressing these challenging mental health conditions.

Table of Contents

Introduction

OSU6162, also known as 3-(3-methanesulfonyl-phenyl)-1-propyl-piperidine hydrochloride, is a promising medication currently being studied for its potential in treating depression and bipolar disorder. This article will provide an overview of OSU6162, its potential uses, and the ongoing research to evaluate its effectiveness and safety.[1][2]

What is OSU6162?

OSU6162 is a drug that is being investigated for its potential to treat mental health conditions. It is also known by other names, including PNU-96391 hydrochloride and OSU-6162 hydrochloride. The medication comes in the form of a coated tablet and is taken orally.[1][2]

OSU6162 as a Treatment for Depression

One of the main areas of research for OSU6162 is its potential use in treating depression, particularly in cases where other treatments have not been effective. Researchers are studying whether adding OSU6162 to existing treatments with selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) can help patients who haven’t responded well to these medications alone.[1]

This research is particularly important because many people with depression don’t get better with standard treatments. The study aims to see if OSU6162 can help improve symptoms in these cases.

OSU6162 for Bipolar Depression

Another area of research for OSU6162 is its potential use in treating bipolar depression. Bipolar depression is the depressive phase of bipolar disorder, a condition characterized by alternating periods of depression and mania or hypomania.[2]

Researchers are conducting an open-label study to assess how well OSU6162 works for people with bipolar depression and how well patients tolerate the medication. This research is important because finding effective treatments for bipolar depression can be challenging, and new options are needed.

How OSU6162 Works

OSU6162 is described as a dopaminergic stabilizer. This means it affects the way the brain uses dopamine, a neurotransmitter involved in mood regulation. While the exact mechanism is still being studied, it’s believed that OSU6162 may help balance dopamine activity in the brain, which could potentially improve mood symptoms in depression and bipolar disorder.[2]

Dosage and Administration

In the ongoing studies, OSU6162 is being tested in the form of 15 mg coated tablets taken orally. The maximum daily dose being studied is 135 mg. However, it’s important to note that these dosages are part of research trials and may not reflect final recommendations if the drug is approved for general use.[1][2]

Potential Side Effects and Precautions

As OSU6162 is still in the research phase, a complete profile of its side effects is not yet available. However, the studies have some exclusion criteria that give us an idea of potential concerns:

  • People with certain heart conditions, particularly those affecting heart rhythm, may need to avoid the medication.
  • The drug may interact with other medications, particularly those that affect liver enzymes or dopamine in the brain.
  • People with a history of substance abuse, certain mental health conditions, or specific medical conditions may not be suitable candidates for the medication.[1][2]

Ongoing Research and Future Prospects

OSU6162 is currently being studied in clinical trials to determine its effectiveness and safety. These trials involve carefully selected participants and controlled conditions. The results of these studies will help determine whether OSU6162 could become an approved treatment option in the future.[1][2]

It’s important to note that while the initial research is promising, OSU6162 is not yet approved for general use. Patients should not attempt to use this medication outside of approved clinical trials. Always consult with a healthcare provider about treatment options for depression or bipolar disorder.

Aspect Trial 1: SSRI/SNRI-Resistant Depression Trial 2: Bipolar Depression
Study Design Double-blind, placebo-controlled Open-label, flexible dose
Main Objective Assess effect and tolerability as add-on to SSRI/SNRI Preliminary assessment of efficacy and tolerability
Primary Endpoint Change in Bech 6-item subscale of HDRS Change in MADRS score
Age Range 25-65 years 18-65 years
Key Inclusion Criteria MADRS score ≥22, SSRI/SNRI-resistant Bipolar I or II, Bech 6-item subscale score ≥10
Maximum Daily Dose 135 mg 135 mg
Treatment Duration 10 weeks 8 weeks

FAQ

  • What is OSU6162 and what is it being studied for? OSU6162 is a drug also known as 3-(3-Methanesulfonyl-Phenyl)-1-Propyl-Piperidine Hydrochloride. It is being studied as a potential treatment for depression resistant to SSRI/SNRI medications and for bipolar depression.
  • How is OSU6162 administered in these clinical trials? In both trials, OSU6162 is administered orally in the form of 15 mg coated tablets. The maximum daily dose in both studies is 135 mg.
  • What are the main objectives of these clinical trials? The first trial aims to assess the effect and tolerability of adding OSU6162 to ongoing SSRI/SNRI treatment in patients with resistant depression. The second trial seeks to preliminarily assess the possible efficacy and tolerability of OSU6162 in bipolar depression.
  • Who can participate in these clinical trials? Participants must be adults aged 18-65 (25-65 for the first trial) with diagnosed depression or bipolar disorder. They must meet specific criteria, including certain depression scores and, for the bipolar study, be on a stable dose of a mood stabilizer.
  • What are some of the exclusion criteria for these trials? Common exclusion criteria include a history of substance abuse, certain psychiatric conditions, significant medical issues, and use of specific medications that might interact with OSU6162. Pregnant or nursing women are also excluded.

Ongoing Clinical Trials on 3-(3-Methanesulfonyl-Phenyl)-1-Propyl-Piperidine Hydrochloride

  • Study on Adding OSU6162 to Treatment for Patients with Depression Resistant to SSRI/SNRI Medications

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • A Study of OSU6162 in Adults with Bipolar Depression to Evaluate Safety and Effectiveness

    Not yet recruiting

    1 1
    Investigated drugs:
    Sweden

Glossary

  • SSRI: Selective Serotonin Reuptake Inhibitor, a type of antidepressant medication that increases serotonin levels in the brain.
  • SNRI: Serotonin and Norepinephrine Reuptake Inhibitor, a type of antidepressant medication that increases both serotonin and norepinephrine levels in the brain.
  • Bipolar Disorder: A mental health condition characterized by alternating periods of depression and mania or hypomania.
  • MADRS: Montgomery-Åsberg Depression Rating Scale, a tool used to measure the severity of depressive episodes in patients with mood disorders.
  • DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th edition, a standard reference for diagnosing mental health conditions.
  • MINI: Mini International Neuropsychiatric Interview, a short diagnostic structured interview used to diagnose psychiatric disorders.
  • QTc-time: A measurement of the heart's electrical cycle, used to assess the risk of certain heart rhythm problems.
  • Mood Stabilizer: A type of medication used to treat bipolar disorder, helping to prevent mood swings between depression and mania.
  • YMRS: Young Mania Rating Scale, a tool used to assess manic symptoms in patients with bipolar disorder.

References

  1. http://clinicaltrials.eu/trial/study-on-adding-osu6162-to-treatment-for-patients-with-depression-resistant-to-ssri-snri-medications/
  2. http://clinicaltrials.eu/trial/study-of-osu6162-for-patients-with-bipolar-depression/