Hygienic-dietary recommendations in patients with Depressio
- Conditions
- DepressionMental and Behavioural DisordersDepressive episode
- Registration Number
- ISRCTN59506583
- Lead Sponsor
- Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1. Patients of both sexes over 18 years
2. Patients experiencing a depressive episode according to DSM-IV-TR diagnostic criteria (Major depressive disorder, Dysthymic disorder or Bipolar disorder depressive phase)
3. Patient receiving antidepressant treatment
4. Patient who has the ability to communicate and give informed consent in writing
5 . Women of childbearing age using a secure contraception
1. Patients suffering from another disease that affects CNS (cerebral organic pathology or who has suffered any serious head injury, dementia, etc.)
2. Other psychiatric diagnosis or severe psychiatric illness (substance dependence and abuse, schizophrenia or other psychotic disorders, eating disorders, etc.), except anxious pathology or personality disorders
3. Presence of medical condition severe, uncontrolled, or potentially interfering with affective symptomatology
4. Presence of delusions or hallucinations at the time of the study
5. Significant risk of suicide
6. Pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Score on Hamilton Scale for Depression (HAMD-17) obtained by blinded assessors before and after intervention.
- Secondary Outcome Measures
Name Time Method 1. Self-administered Beck Depression Inventory (BDI-21)<br>2. Clinical Global Impression scale (CGI)<br>3. SF-36 Health Status (Short-Form SF-36)<br>All outcomes were measured in the screening visit and final visit after 6 months.