Bipolar DisorderNCT04923204
Utility of the Pharmacogenetic Information Provided by NEUROPHARMAGEN in the Treatment of Bipolar Depressionwith Bipolar Depression
An observational study of Bipolar Disorder, run by AB Biotics, SA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Pharmacogenomic-testing with NEUROPHARMAGEN
- Type of treatment
- Injection or infusion
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2016to 5 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Any serious or terminal medical organic disease
- Mental retardation (defined as an intelligence quotient <85)
- Electroconvulsive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Pharmacogenomic-testing with NEUROPHARMAGEN
- Keywords
- Mood disorders, Pharmacogenomic Testing, Precision Medicine, Adverse events, Treatment response
- Medical subject headings
- Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic-testing with NEUROPHARMAGENDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Pharmacogenomic-testing with NEUROPHARMAGEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the time of enrollment (current status after end of index episode)
Secondary outcomes (5)
Hamilton Rating Scale for Depression Rating Scale (HAM-D)
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.
Measured: At the time of enrollment (current status after end of index episode)
Functioning Assessment Short Test (FAST)
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.
Measured: At the time of enrollment (current status after end of index episode)
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).
Measured: At onset of index episode (baseline)
Presence of mood switch
Sudden transition from a depressive mood episode to an episode of mania or hypomania.
Measured: Baseline (onset of index episode) to 6 months (or end of the episode)
Number and type of adverse effects
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.
Measured: Baseline (onset of index episode) to 6 months (or end of the episode)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Mar 2016
- Primary completion31 Mar 2016
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
- Investigators
- Eduard Vieta, MD, PhD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923204
- Sponsor's protocol ID
- PGx-BP
- Status last verified
- Jun 2021
- First submitted
- 3 May 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 31052247Grande 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.
PubMed 26388529Han 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.
PubMed 30466219Ielmini 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.
PubMed 29588611Kato 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.
PubMed 18982004Kawaguchi 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.
PubMed 25303296Lett 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.
PubMed 21894153Mas 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.
PubMed 25499605Menchon 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.
PubMed 29728861Niitsu 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.
PubMed 23733030Perez 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.
PubMed 28705252Porcelli 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.
PubMed 22137564Vilches 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.
PubMed 31480800
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variations Associated With the Therapeutic Response and Profile of Adverse Effects in the Treatment of Bipolar Depression
- ClinicalTrials.gov ID
- NCT04923204
- Acronym / sponsor ID
- PGx-BP
- Conditions
- Bipolar Disorder
- Keywords
- Mood disorders, Pharmacogenomic Testing, Precision Medicine, Adverse events, Treatment response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar depression pharmacogenetics | – | Diagnostic Test: Pharmacogenomic-testing with NEUROPHARMAGENPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Any serious or terminal medical organic disease
- Mental retardation (defined as an intelligence quotient <85)
- Electroconvulsive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenomic-testing with NEUROPHARMAGENThis 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. | Diagnostic test | Bipolar depression pharmacogenetics |
Primary outcome
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).
5 secondary outcomes
Hamilton Rating Scale for Depression Rating Scale (HAM-D)
Time frame: 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)
Clinical Global Impression for Bipolar Disorder (CGI-BP-M)
Time frame: 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)
Number and type of adverse effects
Time frame: Baseline (onset of index episode) to 6 months (or end of the episode)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Background: PubMed 31052247Callegari 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.
- Background: PubMed 26388529Grande 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.
- Background: PubMed 30466219Han 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.
- Background: PubMed 29588611Ielmini 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.
- Background: PubMed 18982004Kato 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.
- Background: PubMed 25303296Kawaguchi 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.
- Background: PubMed 21894153Lett 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.
- Background: PubMed 25499605Mas 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.
- Background: PubMed 29728861Menchon 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.
- Background: PubMed 23733030Niitsu 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.
- Background: PubMed 28705252Perez 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.
- Background: PubMed 22137564Porcelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Vieta, MD, PhD study director
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by AB Biotics, SA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression for Bipolar Disorder (CGI-BP-M) (time frame: At the time of enrollment (current status after end of index episode)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923204, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.