major depression disorder. Depressive episode
Conditions
Interventions
Intervention 1: Buspirone 15mg and Melatonin 3mg Combination (BMC-15/3) for 8 weeks. Intervention 2: one placebo for 8 weeks.
Treatment - Drugs
Placebo
Buspirone 15mg and Melatonin 3mg Combination (BMC-15/3) for 8 weeks
one placebo for 8 weeks
Sponsors
Hamadan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria:Diagnosed with Major Depressive Disorder (MDD), single or recurrent, and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks in duration, prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5™) and confirmed by the MINI;Has a history of TRD during the current MDE. TRD is defined as failure to achieve and a satisfactory response (e.g., less than 50% improvement of depression symptoms), as perceived by the participant, to at least one “treatment course” of a therapeutic dose of an antidepressant therapy of at least 8 weeks duration. Participants must currently be on a stable (for at least 4 weeks) and adequate (according to the Massachusetts General Hospital Antidepressant Treatment History Questionnaire (MGH ATRQ- Chandler et al, 2010) dose of ongoing antidepressant therapy, of which total duration must be at least 8 weeks;Meet the threshold on the total Montgomery Asberg Depression Rating Scale (MADRS- Montgomery and Asberg, 1979) MADRS score of >20 at both screening and baseline visits (Day -5/-14 and Day 0) ;Concurrent psychotherapy will be allowed if the type (e.g., supportive, cognitive behavioral, insight-oriented) and frequency (e.g., weekly or monthly) of the therapy has been stable for at least four weeks prior to screening and if the type and frequency of the therapy is expected to remain stable during the course of the subject’s participation in the study;Concurrent benzodiazepine and hypnotic therapy (e.g., with zolpidem, zaleplon, eszopiclone, benzodiazepines, or trazodone), and other psychotropic medication (psychostimulants, anticonvulsants, buspirone, lithium, pramipexole, modafinil, T3, antipsychotic agents, atomoxetine, nutraceuticals) will be allowed if the therapy has been stable for at least 4 weeks prior to screening.Exclusion criteria:Patient is receiving melatonin, buspirone, or a monoamine oxidase inhibitor at any dose;History during the current MDE of achieve a satisfactory response (e.g., more than 50% improvement of depression symptoms) to >4 treatment courses of a therapeutic dose of an antidepressant therapy of at least 8 weeks duration during the current episode, according to the MGH ATRQ;Current diagnosis of a Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by DSM-5™), at screening or within three months prior to screening;
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of symptom of depression. Timepoint: before treatment and then weekly in 9 visits. Method of measurement: Montgomery-Asberg Depression ,HAM-D-17: 17-item Hamilton Depression Rating Scale; CGI: Clinical Global Impressions Severity (-S) and Improvement (-I) scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects. Timepoint: before treatment and then weekly in 9 visits. Method of measurement: adverse effects form. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArezoo Sajadi
Hamadan University of Medical Sciences
Outcome results
None listed