Vortioxetine Adjunctive Treatment in Bipolar Depression

• Status: Active, not recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Depressive episode of bipolar disorder is often the first symptom of patients with bipolar disorder, which is characterized by frequent recurrence, relatively long duration, high comorbidity rate and high fatality rate. People with bipolar disorder spend a third of their lives depressed, and it is these depressive symptoms that lead to long-term disability and early death. The treatment of bipolar depression is controversial. The latest Mood Disorders CPG guidelines recommend first-line therapy: quetiapine, lurasidone, lithium, valproate, lamotrigine monotherapy or combination of quetiapine, lurasidone plus Mood stabilizer, olanzapine plus fluoxetine therapy. In addition, the use of antidepressants is still controversial, and their efficacy, prognosis and risk of mania remain to be evaluated. Vortioxetine is a novel antidepressant with unique characteristics, and its multi-mode mechanism of action can be used to treat a wide spectrum of symptoms of depression. Current clinical experience suggests that the clinical conversion rate of vortioxetine is low, and the depressive symptoms and cognitive symptoms of people with depressive episodes are significantly improved. As of September 2019, a total of 4.87 million patient years (nearly 3 months of treatment with 20 million patients) were treated with vortioxetine in PSUR (Periodic Safety Update), with 51 reported cases of hypomania and 322 reported cases of mania. Based on the above data, the post-marketing conversion rate of vortioxetine is approximately 1 in 10,000 patient-years or 1 in 40,000 patients. Therefore, the efficacy and risk of transferring to mania of vortioxetine in bipolar II depressive episode deserve further investigation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

1. BMI between >18.5 and <29.5 kg

2. The MINI-International Neuropsychiatric Interview is adopted and patients selected shall meet the clinical diagnostic criteria stipulated in DSM-5 on clinical diagnostic criteria for type II bipolar depression.

3. HDRS17>17

4. YMRS score <5;

5. No treatment was given before enrollment;

6. All patients and their family members were informed and agreed to this trial.

Exclusion Criteria:

1. Those who suffering from other severe mental diseases;

2. Those who suffering from severe somatic diseases;

3. Those who had received medication (such as anti-depressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;

4. Those who had been treated with ECT one month before enrollment;

5. Those who currently have severe suicidal thoughts or behavior, or who are extremely excited and fail to cooperate with;

6. Women in pregnancy and lactation;

7. Patients with contraindications to drugs used in this trial;

8. Those who have participated in a clinical trial of an investigational product in the last 60 days

10) Substance misuse/abuse