nightmare
Conditions
Interventions
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: A patient who meets all the following criteria will be eligible for inclusion in the current study: (1) Chinese aged 18-65 years old; (2) The patient is capable of giving informed consent; (3) The patient suffers from major depressive disorder as the primary diagnosis according to MINI criteria; (4) The patient reports to have nightmares of at least once per week; (5) The patient is able to comply with the trial protocol.
Exclusion criteria
Exclusion criteria: A patient who meets one or more of the following criteria will not be eligible for inclusion in the current study: (1) The patient with a current or past history of manic or hypomanic episode, schizophrenia, mental retardation, organic mental disorder, or PTSD; (2) The patient, in the opinion of the investigator, has a significant risk of suicide, or has suicidality as assessed by MINI greater than moderate, or has made a suicide attempt in the previous 3 months; (3) The patient is pregnant or breast-feeding; (4) The patients has been enrolled in any other clinical trial investigational products within 30 days of the first visit (baseline); (5) The patient has a clinically unstable medical condition or takes medication that, as judged by the investigator, could interfere with the assessments of safety, tolerability or efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of Nightmar; | — |
Countries
China