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Sodium valproate and escitalopram in the treatment of severe depression patients with mixed characteristics of acute phase: an open randomized controlled trial

Sodium valproate and escitalopram in the treatment of severe depression patients with mixed characteristics of acute phase: an open randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048741
Enrollment
Unknown
Registered
2021-07-15
Start date
2021-09-10
Completion date
Unknown
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Group 1:Antidepressant
Group 2:Mood stabilizer

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The brief international neuropsychiatric interview (MINI) version is used for evaluation, which meets the diagnostic criteria for major depressive disorder, and both single depressive episode and recurrent depressive disorder are acceptable; 2. Using DSM-5 assessment, meet the diagnostic criteria for depressive episodes with mixed features; 3. Hamilton 17-item depression scale (HAMD-17) >= 17 points; 4. Aged 16 to 60 years old, both outpatient and inpatient; 5. Patients voluntarily participated in the study and signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who meet the diagnosis of bipolar disorder, schizophrenia, other psychotic disorders, personality disorders or mental retardation; 2. Those who have a history of substance abuse or dependence in the 12 months before enrollment; 3. Those with obvious suicidal tendencies or HAMD-17 item 3 (suicide item) score >= 3; 4. Those with severe and unstable physical diseases; 5. Those who are allergic to or ineffective to the study drug (sodium valproate or escitalopram oxalate) in the past; 6. Women who are pregnant or breastfeeding, or who plan to become pregnant, or who do not agree to use contraception; 7. Those who have received electroconvulsive therapy within 1 month before enrollment; 8. Participated in another interventional clinical investigator in the past year.

Design outcomes

Primary

MeasureTime frame
Patient Health Questionnare, PHQ-9;Generalized Anxiety Disorder, GAD-7;Hypomania Check List, HCL-33;Snaith-Hamilton Pleasure Scale, SHAPS;Sheehan Disability Scale, SDS;Side Effects Scale;Morisky Medication Adherence Scale, MMAS;Hamilton Depression Rating Scale for Depression -17-item, HAMD-17;Hamilton Depression Rating Scale for Anxiety, HAMA;Young Mania Rating Scale, YMRS;Non-Suicidal Self-Injury Behavior Inventory, NSSI;Columbia Suicide Scale;Drug concentration;Complete remission rate;

Countries

China

Contacts

Public ContactWang Xue

Beijing Anding Hospital, Capital Medical University

xuew37@aliyun.com+86 13466587257

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026