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

NCT04923204 | Completed

• 1 other identifier: PGx-BP
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Mood disorders; Pharmacogenomic Testing; Precision Medicine; Adverse events; Treatment response

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression for Bipolar Disorder (CGI-BP-M)

  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 Outcomes (5)

• Hamilton Rating Scale for Depression Rating Scale (HAM-D)

  At the time of enrollment (current status after end of index episode)

• Functioning Assessment Short Test (FAST)

  At the time of enrollment (current status after end of index episode)

• Clinical Global Impression for Bipolar Disorder (CGI-BP-M)

  At onset of index episode (baseline)

• Presence of mood switch

  Baseline (onset of index episode) to 6 months (or end of the episode)

• Number and type of adverse effects

  Baseline (onset of index episode) to 6 months (or end of the episode)

Study Arms (1)

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

Interventions

Pharmacogenomic-testing with NEUROPHARMAGEN DIAGNOSTIC_TEST

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.

Bipolar depression pharmacogenetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AB Biotics, SA: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (13)

• Callegari C, Isella C, Caselli I, Poloni N, Ielmini M. Pharmacogenetic Tests in Reducing Accesses to Emergency Services and Days of Hospitalization in Bipolar Disorder: A 2-Year Mirror Analysis. J Pers Med. 2019 Apr 30;9(2):22. doi: 10.3390/jpm9020022.

  PMID: 31052247 BACKGROUND

• Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet. 2016 Apr 9;387(10027):1561-1572. doi: 10.1016/S0140-6736(15)00241-X. Epub 2015 Sep 18.

  PMID: 26388529 BACKGROUND

• Han C, Wang SM, Bahk WM, Lee SJ, Patkar AA, Masand PS, Mandelli L, Pae CU, Serretti A. A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial. Clin Psychopharmacol Neurosci. 2018 Nov 30;16(4):469-480. doi: 10.9758/cpn.2018.16.4.469.

  PMID: 30466219 BACKGROUND

• Ielmini M, Poloni N, Caselli I, Espadaler J, Tuson M, Grecchi A, Callegari C. The utility of pharmacogenetic testing to support the treatment of bipolar disorder. Pharmgenomics Pers Med. 2018 Mar 16;11:35-42. doi: 10.2147/PGPM.S160967. eCollection 2018.

  PMID: 29588611 BACKGROUND

• Kato M, Serretti A. Review and meta-analysis of antidepressant pharmacogenetic findings in major depressive disorder. Mol Psychiatry. 2010 May;15(5):473-500. doi: 10.1038/mp.2008.116. Epub 2008 Nov 4.

  PMID: 18982004 BACKGROUND

• Kawaguchi DM, Glatt SJ. GRIK4 polymorphism and its association with antidepressant response in depressed patients: a meta-analysis. Pharmacogenomics. 2014 Aug;15(11):1451-9. doi: 10.2217/pgs.14.96.

  PMID: 25303296 BACKGROUND

• Lett TA, Wallace TJ, Chowdhury NI, Tiwari AK, Kennedy JL, Muller DJ. Pharmacogenetics of antipsychotic-induced weight gain: review and clinical implications. Mol Psychiatry. 2012 Mar;17(3):242-66. doi: 10.1038/mp.2011.109. Epub 2011 Sep 6.

  PMID: 21894153 BACKGROUND

• Mas S, Gasso P, Ritter MA, Malagelada C, Bernardo M, Lafuente A. Pharmacogenetic predictor of extrapyramidal symptoms induced by antipsychotics: multilocus interaction in the mTOR pathway. Eur Neuropsychopharmacol. 2015 Jan;25(1):51-9. doi: 10.1016/j.euroneuro.2014.11.011. Epub 2014 Nov 29.

  PMID: 25499605 BACKGROUND

• Menchon JM, Espadaler J, Tuson M, Saiz-Ruiz J, Bobes J, Vieta E, Alvarez E, Perez V. Patient characteristics driving clinical utility in psychiatric pharmacogenetics: a reanalysis from the AB-GEN multicentric trial. J Neural Transm (Vienna). 2019 Jan;126(1):95-99. doi: 10.1007/s00702-018-1879-z. Epub 2018 May 4.

  PMID: 29728861 BACKGROUND

• Niitsu T, Fabbri C, Bentini F, Serretti A. Pharmacogenetics in major depression: a comprehensive meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Aug 1;45:183-94. doi: 10.1016/j.pnpbp.2013.05.011. Epub 2013 Jun 1.

  PMID: 23733030 BACKGROUND

• Perez V, Salavert A, Espadaler J, Tuson M, Saiz-Ruiz J, Saez-Navarro C, Bobes J, Baca-Garcia E, Vieta E, Olivares JM, Rodriguez-Jimenez R, Villagran JM, Gascon J, Canete-Crespillo J, Sole M, Saiz PA, Ibanez A, de Diego-Adelino J; AB-GEN Collaborative Group; Menchon JM. Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial. BMC Psychiatry. 2017 Jul 14;17(1):250. doi: 10.1186/s12888-017-1412-1.

  PMID: 28705252 BACKGROUND

• Porcelli S, Fabbri C, Serretti A. Meta-analysis of serotonin transporter gene promoter polymorphism (5-HTTLPR) association with antidepressant efficacy. Eur Neuropsychopharmacol. 2012 Apr;22(4):239-58. doi: 10.1016/j.euroneuro.2011.10.003. Epub 2011 Dec 3.

  PMID: 22137564 BACKGROUND

• Vilches S, Tuson M, Vieta E, Alvarez E, Espadaler J. Effectiveness of a Pharmacogenetic Tool at Improving Treatment Efficacy in Major Depressive Disorder: A Meta-Analysis of Three Clinical Studies. Pharmaceutics. 2019 Sep 2;11(9):453. doi: 10.3390/pharmaceutics11090453.

  PMID: 31480800 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Eduard Vieta, MD, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: June 11, 2021
• Study Start: March 1, 2016
• Primary Completion: March 31, 2016
• Study Completion: December 5, 2019
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)