Effect of Pharmaceutical Care in Patients With Bipolar I Disorder (BD I)

Effect of Pharmaceutical Care in Patients With Bipolar I Disorder at St John of God Clinic. Randomized Trial.

This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve compliance and adherence rate, associated with greater effectiveness and safety of drug therapy to help achieve therapeutic goals, and finally to improving the quality of life of patients.

The objective of the present study was to assess the effectiveness of the Dader Method for pharmaceutical care in the reduction of the use of health care services and the increase in the effectiveness and safety of treatment in patients with Bipolar I Disorder who are discharged or referred for outpatient clinic St John of God-La Ceja. Primary objective: To assess the effectiveness of the Dader method for pharmaceutical care on achieving in reducing the number of hospital readmissions, in the increase of the effectiveness and safety of treatment in patients discharged from the Clinic of Saint John of God -La Ceja - Antioquia with bipolar disorder.

A randomized controlled trial. 200 patients will be randomized to group of control or intervention. Post-randomisation, patients will be required to attend the clinic routinely every 3 months during one year. Every 3 months will be evaluated on the criteria of effectiveness and safety of the treatment. Intervention's group will be following through pharmaceutical care. In the development of the study will be a record of the use of health care services (rehospitalizations, care emergency and outpatient, additional to those scheduled).

Inclusion Criteria:

• Patients diagnosed with Bipolar I Disorder
• Have been discharged from the Clinic of Saint John of God -La Ceja-
• Have been resulting from external consultation (outpatient) of the Clinic of Saint John of God -La Ceja-
• Male and female patients aged between 18 and 65 years
• Living in Medellin or any of the following eastern municipalities in the department of Antioquia.

Exclusion Criteria:

• Patients with first episode of manic type, schizoaffective disorder, bipolar disorder II, cyclothymia and other bipolar spectrum disorders, personality disorders that seem bipolar disorder, sociopathic disorder.
• Epilepsy
• Patients unable to comply with the protocol requirements, including severe alcohol and drug use.
• Patients with diagnostic uncertainty.
• Pregnancy or breastfeeding
• Infection with the human immunodeficiency virus (HIV).
• Chronic decompensate disease (no significant diseases): blood pressure values above 180/110 mmHg, total cholesterol above 300 mg / dL, low density cholesterol greater than 160 mmHg, hemoglobin A1c greater than 9%, lower oxygen saturation 90%.
• Mental retardation, presence of any cognitive impairment that prevents understands and signs informed consent.
• Refusal to sign informed consent (Consent must be obtained before any study-related procedures are conducted).
• Illiteracy.
• Patients in electroconvulsive therapy.