Utility of the Pharmacogenetic Information Provided by NEUROPHARMAGEN in the Treatment of Bipolar Depressionwith Bipolar Depression

June 8, 2021 updated by: AB Biotics, SA

Genetic Variations Associated With the Therapeutic Response and Profile of Adverse Effects in the Treatment of Bipolar Depression

Evaluation of the impact of the genetic variation of individual genes on the therapeutic response and side effects profile in a cohort of well-characterized patients with bipolar depression, using NEUROPHARMAGEN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bipolar disorder (BD) is a severe psychiatric condition characterized by mood swings between (hypo)mania and depression, with a total lifetime prevalence of 2.4%. An early and effective therapeutic approach is key for the patient prognosis, being the pharmacotherapy the main therapeutic tool for its management.

Treatment guidelines for BD include a variety of psychotropic medications, including lithium, anticonvulsants, antipsychotics, antidepressants, anxiolytics, and combinations of these medications. However, treatment response is often inadequate and poor tolerability is frequently observed.

Variability in treatment efficacy and tolerability has been shown to be influenced by several factors, including the inherited genetic variation. Several meta-analyses have shown that some genetic variants influence the probability of response to selective serotonin reuptake inhibitors (SSRIs) in patients with depression. Similarly, specific genetic polymorphisms have been associated with the risk of certain antipsychotic-induced adverse effects in patients with schizophrenia. However, the impact of many these variants has not been studied in the context of bipolar disorder.

NEUROPHARMAGEN is a pharmacogenomic-based decision support tool that helps clinicians in the selection and dosing of psychoactive drugs based on the integration of pharmacogenetic information, among other patient's characteristics that influence the medication success.

The clinical utility of NEUROPHARMAGEN has been evaluated in major depression disorder (MDD) through randomized clinical trials with hundreds of patients. Two small pilot trials in bipolar patients have suggested a potential clinical utility of this tool in this patient population. However, the output of pharmacogenomic-based tools such as NEUROPHARMAGEN is based in the analysis of several genes, which could differ in their individual clinical utility in a disorder-related manner.

This observational, retrospective, epidemiological study includes 76 patients who attended the Bipolar Disorder Program of the Psychiatry Service of the Hospital Clinic de Barcelona (Spain) with the aim of objectively evaluate the impact of the genetic variation in individual genes on the therapeutic response and side effects profile in this cohort, using NEUROPHARMAGEN.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who attended the Bipolar Disorder Program of the Psychiatry Service of the Hospital Clinic de Barcelona (Barcelona, Spain) for at least 6 months since the beginning of the index episode of the bipolar depression.

Description

Inclusion Criteria:

  • 18 years and older
  • Diagnosis of bipolar disorder with an index episode (IE) of depression with or without associated psychotic symptoms, according to the Diagnostic Manual of Mental Disorder 4th Edition Text Revision (DSM-IV-TR)
  • Written informed consent to participate in the study
  • Attending the Bipolar Disorder Program of the Psychiatry Service of the Hospital Clinic de Barcelona (Spain) for at least 6 months since the beginning of the index episode of the bipolar depression.

Exclusion Criteria:

  • Any serious or terminal medical organic disease
  • Mental retardation (defined as an intelligence quotient <85)
  • Electroconvulsive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bipolar depression pharmacogenetics
Patients 18 years and older, with a diagnosis of bipolar disorder with an index episode of depression with or without associated psychotic symptoms (according to the Diagnostic Manual of Mental Disorder 4th Edition Text Revision, DSM-IV-TR), who attended the Bipolar Disorder Program of the Psychiatry Service of the Hospital Clínic de Barcelona (Spain).
Diagnostic test: Pharmacogenomic-testing with NEUROPHARMAGEN

This observational retrospective study aims at evaluating the impact of the genetic variation in individual genes on the therapeutic response and side effects profile in a bipolar disorder cohort, using NEUROPHARMAGEN.

NEUROPHARMAGEN is a pharmacogenomic-based decision support tool that helps clinicians in the selection and dosing of psychoactive drugs based on the integration of pharmacogenetic information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression for Bipolar Disorder (CGI-BP-M)
Time Frame: At the time of enrollment (current status after end of index episode)
The CGI-BP-M is a modified version of the Clinical Global Impression for Bipolar Disorder for the assessment of manic, hypomanic, depressive or mixed symptoms, long-term outcome of bipolar disorder, and the assessment of the efficacy of several treatments. It consists of three subdomains (depression, mania, and overall), each of them with scoring from 1 (normal) to 7 (extremely ill patients).
At the time of enrollment (current status after end of index episode)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression Rating Scale (HAM-D)
Time Frame: At the time of enrollment (current status after end of index episode)
HAM-D rates the clinical severity of depression. It has 17 questions, each with three to five possible answers, with scores ranging from 0 to 2 or from 0 to 4, respectively. The total score ranges from 0 to 52 and cut-off scores can be used to classify the depressive disorder.
At the time of enrollment (current status after end of index episode)
Functioning Assessment Short Test (FAST)
Time Frame: At the time of enrollment (current status after end of index episode)
FAST is a brief instrument designed to assess the main functioning problems experienced by psychiatric patients, particularly bipolar patients. It comprises 24 items that assess impairment or disability in six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. All of items are rated using a 4-point scale (0 = no difficulty, 1 = mild difficulty, 2 = moderate difficulty and 3 = severe difficulty). The global score is obtained by adding up the scores of each item. The higher the score, the more serious the difficulties are.
At the time of enrollment (current status after end of index episode)
Clinical Global Impression for Bipolar Disorder (CGI-BP-M)
Time Frame: At onset of index episode (baseline)
The CGI-BP-M is a modified version of the Clinical Global Impression for Bipolar Disorder for the assessment of manic, hypomanic, depressive or mixed symptoms, long-term outcome of bipolar disorder, and the assessment of the efficacy of several treatments. It consists of three subdomains (depression, mania, and overall), each of them with scoring from 1 (normal) to 7 (extremely ill patients).
At onset of index episode (baseline)
Presence of mood switch
Time Frame: Baseline (onset of index episode) to 6 months (or end of the episode)
Sudden transition from a depressive mood episode to an episode of mania or hypomania.
Baseline (onset of index episode) to 6 months (or end of the episode)
Number and type of adverse effects
Time Frame: Baseline (onset of index episode) to 6 months (or end of the episode)
Sociodemographic and clinical data, including the pharmacological treatment in the index episode (IE) and mood switch (the latter for those patients applicable), and the presence and type of side effect associated with the pharmacological treatment in the IE were extracted from all enrolled subjects. The adverse events recorded were as follows: weight gain, dyslipidemia (cholesterol, LDL, HDL, triglycerides), glucose, sedation, extrapyramidal symptoms, seizures, neuroleptic malignant syndrome, corrected QT interval prolongation, sexual dysfunction, and hyperprolactinemia.
Baseline (onset of index episode) to 6 months (or end of the episode)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Biotics, SA

Collaborators

Hospital Clinic of Barcelona

Investigators

  • Study Director: Eduard Vieta, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

December 5, 2019

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGx-BP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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