CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 92 enrolled
Drug / intervention
Pharmaceutical Care +1 moreother
Likely dose
Not stated in record
Key inclusion· 4
  • Diagnosed with Bipolar I Disorder
  • Age 18-65 years
  • Recently discharged from or receiving outpatient care at Saint John of God Clinic in La Ceja
  • Living in Medellin or eastern municipalities of Antioquia department
Key exclusion· 13
  • First episode of mania
  • Bipolar II disorder, schizoaffective disorder, or other bipolar spectrum disorders
  • Personality disorders mimicking bipolar disorder or sociopathic disorder
  • Epilepsy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01750255
NCT01750255N/ACompleted

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

Universidad de Antioquia·interventional·Posted Dec 17, 2012·Updated Sep 16, 2016

In Brief

A clinical study evaluating Pharmaceutical Care and Education for Bipolar Disorder. Completed, enrolled 92 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesColombia

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2012
Enrollment StartNov 1, 2011
Primary CompletionMay 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.5 years ago

Interventions

Pharmaceutical Careother

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

Educationother

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.