Bipolar Disorder. Mania episode
Conditions
Interventions
Treatment - Drugs
Placebo
Intervention group: Lithium Carbonate 900 mg/day and risperidone 3mg per day plus melatonin 6 mg/day for 6 weeks
Control group: Lithium Carbonate 900 mg/day and risperidone 3mg/day plus placebo for 6 weeks
Intervention 1: Intervention group: Lithium Carbonate 900 mg/day and risperidone 3mg per day plus melatonin 6 mg/day for 6 weeks. Intervention 2: Control group: Lithium Carbonate 900 mg/day and rispe
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: meeting the DSM-5 criteria for Bipolar Disorder; age between 18 and 65 years; a score of at least 20 points on the Young Mania Rating Scale. Exclusion criteria: hyper- or hypothyroidism; substance dependence(except for Nicotine and caffeine); IQ lower than 70; history of allergy to lithium, risperidone and melatonin; lactating or pregnant women; receiving medications causing manic like symptoms including stimulants; cardiac conducting disturbance; serious risk of suicide.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of mania. Timepoint: Baseline and weerks 1, 2, 4, 6. Method of measurement: by Young Mania Rating Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of extrapyramidal side effects. Timepoint: Baseline and weerks 1, 2, 4, 6. Method of measurement: By Extrapyramidal Symptom Rating Scale(ESRS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactProf. Shahin Akhondzadeh
Tehran University of Medical Sciences
Outcome results
None listed