In short
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.
Key points
- Clinical trials investigating Venlafaxine focus mainly on depression-related conditions, including major depressive disorder, severe depressive episodes, and bipolar depression. One trial also studies Venlafaxine for hot flashes in women after breast cancer treatment. Most studies are Phase 3, with one Phase 4 study in adults with major depressive disorder. The trials include different groups such as adults with depression, inpatients with severe symptoms, people with stable remission stopping antidepressants, and women using endocrine therapy after breast cancer. The main outcomes are changes in depression scores, hot flash burden, withdrawal symptoms, and treatment response over time.
Trial overview
The trial data show that Venlafaxine is being studied in several different research settings, mostly for depression-related conditions. The studies include people with major depressive disorder, depression, bipolar depression, severe major depressive episodes, and women with hot flashes after breast cancer treatment.
Most of the studies are Phase 3 trials, which means they are testing Venlafaxine in larger groups and comparing outcomes across treatment arms. One study in adults with major depressive disorder is a Phase 4 trial.
Studies in depression and bipolar depression
Several trials focus on people with major depressive disorder or related depressive conditions. 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.
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. Its main goal is to compare change in the MADRS-10 score, a scale that measures depression severity, after 7 days.
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. Venlafaxine is one of many medicines used in that study, and the main outcome is change in MADRS total score at six weeks.
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. The study includes people who had a first-time treatment failure on their first-line treatment.
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. It would have compared symptom change over four to six weeks using different rating scales depending on the diagnosis.
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. It compares two tapering strategies for people using Paroxetine or Venlafaxine, with the goal of finding the best way to discontinue antidepressants.
The main outcome is the rate of failure to successfully discontinue the antidepressant. This includes switching to rescue medication, stopping the protocol, or having significant withdrawal symptoms during the discontinuation phase.
Hot flash study after breast cancer
One Phase 3 trial studies women using endocrine therapy after breast cancer. In this study, Venlafaxine is compared with oxybutynin to see which treatment better reduces hot flashes over 6 weeks.
The main outcome is the number and severity of hot flashes recorded in a daily Hot Flash Diary. This makes the study especially focused on symptom tracking in daily life.
What the trials measure
The trials use different endpoint measures, which are the main results the researchers want to see. In depression studies, the most common endpoints are changes in depression scores such as MADRS, MADRS-10, or HDRS.
Some studies look beyond symptoms alone. 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.
The hot flash trial uses a daily diary to count both the number and severity of symptoms. The discontinuation trial measures withdrawal symptoms and protocol failures during antidepressant tapering.
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.
The studies are designed for different populations, so participation depends on the condition being studied and the study rules. Some trials focus on adults with depression, some on inpatients with severe major depressive episodes, and one on women after breast cancer treatment.
The largest listed study is the withdrawn multi-diagnosis trial with 1,254 planned participants, while the smallest completed study enrolled 25 people. This shows that Venlafaxine research ranges from small focused studies to large comparative trials.