Vortioxetine Adjunctive Treatment in Bipolar Depression

NCT05481957 | Completed Phase 4 DMC

• 1 other identifier: IIT20210111C-R1
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale(MADRS)

  Montgomery-Asberg Depression Rating Scale(MADRS) score is to evaluate the degree of depression, and the higher score means severer depression. Score frame: 0\~60. The higher score means severer depression.

  0 ~16 weeks

Study Arms (2)

vortioxetine

EXPERIMENTAL

participants given 5\~10mg per day for 16 weeks

Drug: Vortioxetine

Sodium valproate

ACTIVE COMPARATOR

participants given 500\~1000mg per day for 16 weeks

Drug: valprote

Interventions

Vortioxetine DRUG

5-10mg for 16 weeks

Also known as: Brintellix®

vortioxetine

valprote DRUG

500\~1000mg for 16 weeks

Also known as: Depakine

Sodium valproate

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• BMI between \>18.5 and \<29.5 kg
• 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.
• HDRS17\>17
• YMRS score \<5;
• No treatment was given before enrollment;
• All patients and their family members were informed and agreed to this trial.

You may not qualify if:

• Those who suffering from other severe mental diseases;
• Those who suffering from severe somatic diseases;
• Those who had received medication (such as anti-depressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
• Those who had been treated with ECT one month before enrollment;
• Those who currently have severe suicidal thoughts or behavior, or who are extremely excited and fail to cooperate with;
• Women in pregnancy and lactation;
• Patients with contraindications to drugs used in this trial;
• Those who have participated in a clinical trial of an investigational product in the last 60 days
• \) Substance misuse/abuse

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Zhejiang University: collaborator

Study Sites (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Vortioxetine; Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Li YouMing

  Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: March 1, 2022
• Primary Completion: June 28, 2023
• Study Completion: August 15, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)