major depressive disorder
Conditions
Interventions
The experimental group:Perospirone hydrochloride tablets +Selective Serotonin Reuptake Inhibitors/Serotonin-Norepinephrine Reuptake Inhibitors
The control group:Placebo+Selective Serotonin Reuptake Inhibitors/Serotonin-Norepinephrine Reuptake Inhibitors
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD, confirmed by the Mini International Neuropsychiatric Interview (MINI); 2. The current episode duration of MDD must be =1 year; 3. Failed to respond adequately to at least one kind of antidepressant at therapeutic doses for at least 4 weeks, as indicated by a current score of at least 20 on the Montgomery-Asberg Depression Rating Scale (MADRS); 4. Aged 18 ~ 60 years; 5. Education >= 6 years and able to complete the cognitive tests; 6. Having the ability to understand and sign a written informed consent form prior to participation in any screening procedures.
Exclusion criteria
Exclusion criteria: 1. Any other DSM-5 psychiatric disorder other than generalized anxiety disorder and social anxiety disorder diagnosed at present or lifetime; 2. Subjects with serious suicide ideation or attempts; 3. Subjects who have received treatments with adjunctive antidepressants and/or antipsychotic medications in the current depressive episode (small doses of benzodiazepines were permitted); 4. Subjects who have received non-drug treatments in past 6 months for more than 10 times, such as electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), and systemic psychotherapy; 5. DSM-5 alcohol or drug dependence; 6. History of head injury or loss of consciousness for more than 5 minutes; 7. Subjects with a history or current diagnose of major physical illness (such as thyroid disease, lupus erythematosus, diabetes, lung, liver and kidney damage, infection, major trauma and etc.); 8. Pregnant or breast-feeding; 9. Epilepsy, history of seizures or family history of epilepsy; 10. Receiving hormone therapy at present; 11. Transaminases (ALT or AST) 2 times or more above the upper limit of normal range; 12. QTc >= 430 msec (for males) or >= 450 msec (for females) in ECG; 13. Any subject with some other conditions that the researchers believe may affect the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients with Montgomery-Asberg Depression Rating Scale reduction =50% at the end of 4 and 8 weeks;proportion of patients with Montgomery-Asberg Depression Rating Scale =10 at the end of 4 and 8 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale reduction rate;Hamilton Anxiety Scale reduction rate;Clinical Global Impression subscale change rate;Beck Suicidal Ideation Scale subscale change rate;PSQI reduction rate;16-Item quick inventory of depressive symptomatology self-report reduction rate;Seven-item Generalized Anxiety Disorder Scale reduction rate;Snaith-Hamilton pleasure scale reduction rate; Sheehan Disability Scale change rate;Quality of Life Enjoyment and Satisfaction Questionnaire Short Form change rate;Change rate of cognitive function test performance; | — |
Countries
China
Contacts
Public ContactLingjiang Li
The Second Xiangya Hospital of Central South University
Outcome results
None listed