bipolar disorder. Bipolar affective disorder
Conditions
Interventions
Intervention 1: Intervention: lithium at doses producing a serum concentration of 0.8-1 meq/l + GBP with a target daily dose of 400mg/day. Intervention 2: Control: lithium at doses producing a serum c
Treatment - Drugs
Intervention: lithium at doses producing a serum concentration of 0.8-1 meq/l + GBP with a target daily dose of 400mg/day
Control: lithium at doses producing a serum concentration of 0.8-1 meq/l + placebo
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
10 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1)10 -17 years of age 2) score more than 20 in Young Mania Rating Scale (YMRS, Yongstorm , et al, 2003) 3)not being on any psychiatric medication for at least two weeks prior to entry into this trial 4) signing a written informed consent. Exclusion criteria: 1) any significant medical illness, 2) IQ lower than70, 3) meeting criteria for substance dependence and abuse in the month before trial
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mania severity. Timepoint: before intervention and every two weeks. Method of measurement: Young Mania ratin Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety severity. Timepoint: before intervention and every two weeks. Method of measurement: Hamilton rating scale.;Depression severity. Timepoint: before intervention and every two weeks. Method of measurement: Beck Depression Inventory.;Side effects. Timepoint: on weeks 2,4,6,8. Method of measurement: side effects checklist. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRozita Davari-Ashtiani
Shahid Beheshti University of Medical sciences
Outcome results
None listed