Brain Derived Neurotrophic Factor as a Predictor of Response to Treatment in Bipolar Depression and Mania

NCT00879632 | Unknown

• 1 other identifier: 07456
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There is sound evidence that quetiapine is effective in the treatment of manic and depressive episodes associated with Bipolar Disorder (BD) (Yatham et al 2006). However, even with the development of effective new treatment options, not all patients respond to treatments available. Biological markers have been investigated as predictors of response to treatment and of remission of symptoms. This would explain in part the individual's differences in the response to treatment, taking into account the genetic variability plus environmental factors influencing specific biological markers. A potential biological marker of response to treatment in BD would be the levels of neurotrophins, as they are, in fact, altered during acute mood episodes (Cunha et al 2006). Among neurotrophins, the Brain-Derived Neurotrophic Factor (BDNF) has been repeatedly and consistently reported to be associated with BD physiopathology (Post 2007). Furthermore, medications that are known to be effective in BD, like lithium and divalproex, increase BDNF levels.

Conditions

BIPOLAR DISORDER

Outcome Measures

Primary Outcomes (1)

• Hamilton depression raing scale and young mania rating scale

  16 weeks

Secondary Outcomes (1)

• Serum BDNF levels as predictor of response to treatment

  16 weeks

Study Arms (2)

1

TREATMENT AS USUAL

2

CONTROLS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bipolar disorders patients during acute mania or depression using treatment as usual

You may qualify if:

• Provision of written informed consent
• A diagnosis of Bipolar Disorder I by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition revised (DSM-IV-TR)
• Males and females aged 18 to 65 years
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotrophin (HCG) test at enrolment
• Able to understand and comply with the requirements of the study
• Currently experiencing a manic, depressive or mixed mood episode, according to DSM-IV-TR. Patients must have a clear DSM-IV diagnosis, confirmed by SCID interview (Structured Clinical Interview for DSM disorders).

You may not qualify if:

• Pregnancy or lactation
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
• Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
• Currently on psychotropic medication or administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation. Wash-out of minimum of 2 weeks will be required for intake. Fluoxetine use or depot antipsychotics will require 6 weeks of wash-out prior to intake.
• Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
• Involvement in the planning and conduct of the study
• Previous enrolment in the present study.
• Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
• A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
• Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) \>8.5%.
• Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

SERUM, DNA, PLASMA

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• FLAVIO KAPCZINSKI, MD, PHD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FLAVIO KAPCZINSKI, MD, PHD

CONTACT

55-51-33598845; flavio.kapczinski@gmail.com

MARCIA SANTANNA, MD, PHD

CONTACT

55-51-33598846; mksantanna@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 10, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 16, 2011

Record last verified: 2011-02

Locations

BR (1)