Bipolar disorder. Bipolar affective disorder
Conditions
Interventions
Intervention 1: This study is a triple blind clinical trial in hospitalized 70 bipolar manic patients meeting inclusion criteria. At the beginning of the trial YMRS and MMSE test will be taken and div
Behavior
Placebo
This study is a triple blind clinical trial in hospitalized 70 bipolar manic patients meeting inclusion criteria. At the beginning of the trial YMRS and MMSE test will be taken and divided randomly in
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1- Age 18 to 59 years old; 2- Diagnosed bipolar I recent episode mania; 3- Rule out schizophrenia delirium anorexia nevroza, bulimia, autism, substance abuse, mental retardation and ADHD; 4- Not hospitalized in psychiatric hospital in last 3 months; 5- Not experienced seizure; 6- Not experienced severe allergic reaction; 7- Filling out the content form; 8- Not experienced severe allergic reaction to valporat and herbal drug. Exclusion criteria: 1- Patients having high risk factors for suicide or homicide; 2- Pregnancy; 3- Patients prescribed other drugs including other anti-manic drugs in 2 weeks before starting or during the trial.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| YMRS in bipolar manic phase. Timepoint: beginning, end of 1st, 2nd and 4th weeks. Method of measurement: YMRS test.;CGI Bipolar manic phase. Timepoint: At the beginning, end of 1st, 2nd and 4th weeks. Method of measurement: CGI test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive state. Timepoint: At the beginning and end of week 4. Method of measurement: MMSE.;Adverse effect GI disturbance and thrombocytopenia. Timepoint: beginning and end of week 4. Method of measurement: LFT, CBC. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Farzad Akbarzade
Mashhad University of Medical Sciences
Outcome results
None listed