Condition 1: Treatment – Resistant Depression. Condition 2: Vitamin D deficiency. Severe depressive episode without psychotic symptoms and Moderate depressive episode Vitamin D deficiency
Conditions
Interventions
Intervention 1: Bupropion 450 mg tablet, daily, oral, up to 3 month + Calcium carbonate 500 mg tablet,oral, BD, up to 3 month + vitamin D3 pearl oral, one perl per week up to 8 weeks and then one pe
Treatment - Drugs
Placebo
Bupropion 450 mg tablet, daily, oral, up to 3 month + Calcium carbonate 500 mg tablet,oral, BD, up to 3 month + vitamin D3 pearl oral, one perl per week up to 8 weeks and then one perl per month up
Bupropion 450 mg tablet, daily, oral, up to 3 month + Calcium carbonate 500 mg tablet,oral, BD, up to 3 month + Placebo vitamin D3 pearl oral, one perl per week up to 8 weeks and then one perl per m
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 18-65 year old patients with treatment resistant depression based on survey by psychologist and DSM IV criteria. The patients who entered the study must be known case of major depression disorder and under treatment with full dose Sertraline at least 4-6 weeks and not responding to treatment. Also their 25-hydroxyvitamin D serum level must be lower than 50 nmol/L or less than 20 ng/ml. Women of reproductive age with negative BHCG that use reliable method of contraception during the study. Exclusion criteria: patients with Sarcoidosis, Tuberculosis, Malignancy, Hypercalcemia, Renal disease (Nephrolithiasis, etc.); known case of malabsorption problems like celiac and etc. and other medical or psychiatric illnesses associated. Pregnant or lactating women are also excluded.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of depression based on Hamilton Depression Rating scale. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Hamilton Depression Rating scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phosphorus serum level mmol/L or mg/dl. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Blood sample taking.;25-hydroxyvitamin D serum level nmol/L or ng/ml. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Blood sample taking.;Calcium serum level mg/dl or mM. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Blood sample taking.;Parathyroid hormoneserum level mmol/L or mg/dl. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Blood sample taking.;Age. Timepoint: Once before initial intervention. Method of measurement: Observation.;Sex. Timepoint: Once before initial intervention. Method of measurement: Observation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Effatpanah
Tehran University of Medical Sciences
Outcome results
None listed