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

Summary

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.

Conditions

• Bipolar Disorder

Interventions

OTHER

Pharmaceutical Care

Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy; Depression and Mania Rating Scale, Clinical Global Assessment Scale, Quality of life and adherence to treatment

OTHER

Education

The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life (Sf - 36 test), adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.

Sponsors & Collaborators

• Humax Pharmaceutical

  collaborator INDUSTRY

• Universidad de Antioquia

  lead OTHER

Principal Investigators

• Andrea Salazar, cDr. · Universidad de Antioquia

• Pedro J Amariles, Dr. · Universidad de Antioquia

• Dora M Benjumea, Dr · Universidad de Antioquia

• Luis F Rodriguez, Dr · Clínica San Juan de Dios

• Francisco J Gutierrez, Dr · Universidad de Antioquia

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2013-05-31

Completion

2014-06-30

Countries

• Colombia

Study Locations