Clinical trial NCT04923204: Utility of the Pharmacogenetic Information Provided by NEUROPHARMAGEN in the Treatment of Bipolar Depressionwith Bipolar Depression
Official title: Genetic Variations Associated With the Therapeutic Response and Profile of Adverse Effects in the Treatment of Bipolar Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Mood disorders
Pharmacogenomic Testing
Precision Medicine
Adverse events
Treatment response
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2021-06-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression for Bipolar Disorder (CGI-BP-M)
timeFrame: At the time of enrollment (current status after end of index episode)
Secondary outcomes:
measure: Hamilton Rating Scale for Depression Rating Scale (HAM-D)
timeFrame: At the time of enrollment (current status after end of index episode)
measure: Functioning Assessment Short Test (FAST)
timeFrame: At the time of enrollment (current status after end of index episode)
measure: Clinical Global Impression for Bipolar Disorder (CGI-BP-M)
timeFrame: At onset of index episode (baseline)
measure: Presence of mood switch
timeFrame: Baseline (onset of index episode) to 6 months (or end of the episode)
measure: Number and type of adverse effects
timeFrame: Baseline (onset of index episode) to 6 months (or end of the episode)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Eduard Vieta, MD, PhD
role: STUDY_DIRECTOR
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