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Efficacy and safety of antidepressant combined with inosine for depressive disorders in children, adolescents and adults: a randomised, double-blind, placebo-controlled trial

Efficacy and safety of antidepressant combined with inosine for depressive disorders in children, adolescents and adults: a randomised, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014637
Enrollment
Unknown
Registered
2018-01-25
Start date
2018-02-01
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

Depressive disorders

Interventions

Children and adolescents treatment group:Fluoxetine+inosine
Children and adolescents control group:Fluoxetine+inosine placebo
Adult treatment group:Fluoxetine+inosine
Adult control group:Fluoxetine+inosine placebo

Sponsors

Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with depressive disorders by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5); (2) Children and adolescents aged from 4 to 17 and adults aged from 18 to 65 years; (3) Children's Depression Rating Scale - Revised (CDRS-R) total scores=40 in children and adolescents and Hamilton Depression Scale - 17 items (HAMD-17) in adults; (4) Providing written informed consent informed consent (children and adolescents need signature of guardian).

Exclusion criteria

Exclusion criteria: (1) Taking drugs that are interfering or contraindicated with the test drugs, taking antidepressants within a month, having serious side effects of test drugs, or being allergic to test drugs; (2) Patients diagnosed with organic mental disorders, mental disorders caused by psychoactive substances, refractory depression (respond poorly to appropriate courses of at least two antidepressants), schizophrenia, bipolar disorder, somatoform disorders; (3) Patients diagnosed with severe physical diseases or in other life-threatening conditions; (4) Having a history of substance abuse such as drug, alcohol or having a risk of suicide; (5) Patients with mental retardation or severe cognitive impairment; (6) Pregnant or nursing women; (7) Participating in the clinical research currently.

Design outcomes

Primary

MeasureTime frame
Depressive symptoms;

Secondary

MeasureTime frame
Anxiety symptoms;Suicide severity;Life quality evaluation;Clinical global impression;Safety evaluation;

Countries

China

Contacts

Public ContactPeng Xie

The First Affiliated Hospital of Chongqing Medical University

xiepeng973@126.com+86 023-68485490

Outcome results

None listed

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