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Venlafaxine

Clinical trials investigating Venlafaxine are studying how it performs in different patient groups, including people with depression, bipolar depression, and women with hot flashes after breast cancer treatment. These studies look at outcomes such as symptom improvement, withdrawal problems, and treatment response.

Table of Contents

Trial overview

The trial data show that Venlafaxine is being studied in several different research settings, mostly for depression-related conditions.[1] The studies include people with major depressive disorder, depression, bipolar depression, severe major depressive episodes, and women with hot flashes after breast cancer treatment.[1][2]

Most of the studies are Phase 3 trials, which means they are testing Venlafaxine in larger groups and comparing outcomes across treatment arms.[1][2] One study in adults with major depressive disorder is a Phase 4 trial.[3]

Studies in depression and bipolar depression

Several trials focus on people with major depressive disorder or related depressive conditions.[1][2] One completed Phase 3 study with 25 participants looked at the link between changes in the gut microbial profile, depression symptoms, and side effects during Venlafaxine treatment.[1]

Another Phase 3 trial in depression is the DEXA-PSYCH study, which includes Venlafaxine among several treatment options in a double-blind, randomised, placebo-controlled design.[2] Its main goal is to compare change in the MADRS-10 score, a scale that measures depression severity, after 7 days.[2]

A separate Phase 3 study in people with major depressive disorder is looking at a six-week intensified drug treatment compared with treatment as usual after a first-time treatment failure.[3] Venlafaxine is one of many medicines used in that study, and the main outcome is change in MADRS total score at six weeks.[3]

There is also a Phase 3 trial in bipolar depression with the same early-intensified treatment idea and the same main outcome measure, the MADRS total score at six weeks.[4] The study includes people who had a first-time treatment failure on their first-line treatment.[4]

One withdrawn Phase 3 study was planned for several diagnoses, including schizophrenia spectrum disorders, major depressive disorder, and bipolar disorder currently in a depressive episode.[5] It would have compared symptom change over four to six weeks using different rating scales depending on the diagnosis.[5]

Stopping antidepressants safely

The TEMPO study is a Phase 3 trial in people with stable remitted major depressive disorder, meaning their depression is currently under control.[6] It compares two tapering strategies for people using Paroxetine or Venlafaxine, with the goal of finding the best way to discontinue antidepressants.[6]

The main outcome is the rate of failure to successfully discontinue the antidepressant.[6] This includes switching to rescue medication, stopping the protocol, or having significant withdrawal symptoms during the discontinuation phase.[6]

Hot flash study after breast cancer

One Phase 3 trial studies women using endocrine therapy after breast cancer.[7] In this study, Venlafaxine is compared with oxybutynin to see which treatment better reduces hot flashes over 6 weeks.[7]

The main outcome is the number and severity of hot flashes recorded in a daily Hot Flash Diary.[7] This makes the study especially focused on symptom tracking in daily life.[7]

What the trials measure

The trials use different endpoint measures, which are the main results the researchers want to see.[1][2] In depression studies, the most common endpoints are changes in depression scores such as MADRS, MADRS-10, or HDRS.[2][3][4][8]

Some studies look beyond symptoms alone.[1][8] The microbiome study measures gut microbial changes, and the ketamine add-on study also explores brain imaging findings with PET-MRI and whether those changes match clinical improvement.[1][8]

The hot flash trial uses a daily diary to count both the number and severity of symptoms.[7] The discontinuation trial measures withdrawal symptoms and protocol failures during antidepressant tapering.[6]

Study design, phases, and participation

Most of the Venlafaxine studies in this dataset are interventional, which means participants receive a planned treatment or comparison treatment.[1][2][3][4][6][7]

The studies are designed for different populations, so participation depends on the condition being studied and the study rules.[1][2][3][4][6][7] Some trials focus on adults with depression, some on inpatients with severe major depressive episodes, and one on women after breast cancer treatment.[2][8][7]

The largest listed study is the withdrawn multi-diagnosis trial with 1,254 planned participants, while the smallest completed study enrolled 25 people.[5][1] This shows that Venlafaxine research ranges from small focused studies to large comparative trials.[1][5]

Trial ID Phase Condition studied Status Enrollment
2024-518101-18-02 Phase 3 Major Depressive Disorder Completed 25
2022-501428-45-00 Phase 3 Depression Authorised 300
NCT05973851 Phase 3 Major depressive disorder Authorised 453
2024-511997-66-00 Phase 3 Major Depressive Disorder Authorised 200
2023-506597-12-00 Phase 3 Major depressive disorder with current severe major depressive episode Authorised 60
NCT06106529 Phase 3 Breast cancer Authorised 67
NCT05973786 Phase 3 Bipolar depression Authorised 458
2022-500538-27-00 Phase 4 Adjunctive therapy to antidepressants for major depressive disorder in adults Completed 944
NCT05603104 Phase 3 Schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder, or bipolar disorder type I/II in a depressive episode Withdrawn 1254

FAQ

  • What kinds of conditions are being studied with Venlafaxine? The trials in this dataset study Venlafaxine in major depressive disorder, depression, bipolar depression, severe depressive episodes, and hot flashes in women using endocrine therapy after breast cancer.
  • Who can take part in these Venlafaxine studies? Different trials include different groups, such as adults with depression, inpatients with severe major depressive episodes, people with stable remitted major depressive disorder, and women after breast cancer treatment. Each study has its own entry rules.
  • What phases are the Venlafaxine trials in? Most of the trials are Phase 3 studies, and one large study in adults with major depressive disorder is Phase 4. The phase tells you how far the study has progressed in testing the treatment.
  • What are the trials trying to measure? The studies measure things like changes in depression scores, hot flash frequency and severity, withdrawal symptoms when stopping antidepressants, and links between treatment response and gut microbes or brain imaging findings.
  • Are all the Venlafaxine trials completed? No. Some are completed, while others are authorised, and one study was withdrawn. This means the research is at different stages.

Ongoing Clinical Trials on Venlafaxine

  • Study on Oxybutynin and Venlafaxine for Reducing Hot Flashes in Women Undergoing Endocrine Therapy After Breast Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Early Effects of Ketamine and Venlafaxine for Hospitalized Patients with Severe Major Depression

    Recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on the Effect of Citalopram, Sertraline, and Lithium for Patients with Bipolar Depression After First-Line Treatment Failure

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Germany Greece Italy Spain

  • Study on the Effect of Ketamine and Esketamine in Patients with Major Depressive Disorder After First-Line Treatment Failure

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Germany Greece Italy Spain

  • Study on Dexamethasone for Patients with Moderate to Severe Depression: Evaluating Its Effectiveness with Mirtazapine, Citalopram, and Nortriptyline

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Enhanced Treatment for Schizophrenia, Depression, and Bipolar Disorder Using Esketamine, Bupropion, and Quetiapine for Patients with Initial Treatment Failure

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Italy Spain

  • Testing Ulotaront Added to Antidepressants for Adults with Major Depressive Disorder Who Did Not Respond Well to Initial Treatment

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Germany Hungary Poland Spain

  • Study on the Effects of Venlafaxine and Gut Microbiome in Patients with Major Depressive Disorder

    Not recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on Stopping Antidepressants: Comparing Tapering Methods for Patients with Major Depressive Disorder Using Venlafaxine or Paroxetine Hydrochloride

    Not recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Major Depressive Disorder (MDD): A mood disorder with ongoing low mood and loss of interest that can affect daily life. Several trials study Venlafaxine in people with MDD.
  • Bipolar depression: A depressive episode that happens in bipolar disorder. One trial studies Venlafaxine in people with bipolar depression.
  • Severe major depressive episode: A very serious period of depression. One trial studies inpatients with this condition.
  • Phase 3: A later stage of clinical testing that compares treatments in larger groups of people to see how well they work and how safe they are in that study setting.
  • Phase 4: A study stage done after a treatment is already in wider use. It often looks at added questions in real-world settings.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Randomised controlled trial: A study where people are assigned by chance to different treatment groups, so the results are more fair to compare.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare the true effect of a treatment.
  • MADRS: The Montgomery-Åsberg Depression Rating Scale, a score used to measure how severe depression symptoms are.
  • HDRS: The Hamilton Depression Rating Scale, another tool used to measure depression symptoms.
  • Hot Flash Diary: A daily record used to track how many hot flashes happen and how severe they are.
  • Withdrawal symptoms: Symptoms that can happen when a medicine is reduced or stopped. One trial measures problems during antidepressant discontinuation.

References