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Assessment of Pituitary Adenylate Cyclase Activating Polypeptide-Brain Derived Neurotrophic Factor (PACAP-BDNF) Signaling System Involvement in Etiology and Treatment of Major Depression

Information source: Tirat Carmel Mental Health Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depression

Intervention: SSRI; SNRI; TCA (Drug)

Phase: N/A

Status: Completed

Sponsored by: Tirat Carmel Mental Health Center

Official(s) and/or principal investigator(s):
Anatoly Kreinin, MD, PhD, Study Chair, Affiliation: The Bruce and Ruth Rappaport Faculty of Medicine, Technion, Haifa
Albert Pinhasov, PhD, Principal Investigator, Affiliation: Department of Molecular Biology at Ariel University Center
Leon Raskin, PhD, Principal Investigator, Affiliation: University of Michigan
Kamal Farhat, MD, Principal Investigator, Affiliation: The Nazareth Hospital-EMMS
Joseph Farah, MD, Principal Investigator, Affiliation: The Nazareth Hospital-EMMS
Klaudia Rybalksy, MD, Principal Investigator, Affiliation: The Nazareth Hospital-EMMS

Summary

The neuropeptide Pituitary Adenylate Cyclase Activating Polypeptide (PACAP) and its receptors PAC1 and VPAC2 are widely expressed in the nervous system. The investigators found that PACAP treatment of neuronal cell cultures increases expression of Brain Derived Neurotrophic Factor (BDNF) that plays an important role in the etiology of psychiatric disorders and action of antidepressants. For the first time, the investigators demonstrated that treatment by Paroxetine and Citalopram significantly decreases PAC1 and VPAC2 and upregulates PACAP mRNA expression, whereas Imipramine shows an opposite effect. Moreover, PACAP, PAC1 and VPAC2 expression is highly correlated with BDNF expression. Their in vivo studies show that Imipramine reduces BDNF and increases PAC1 mRNA expression in murine hippocampus, suggesting that antidepressants may affect neuronal plasticity through PACAP-BDNF interactions. Based on their observations in experimental systems, the investigators hypothesize that PACAP signaling system may be involved in the etiology of depression and mechanism of antidepressant action. The investigators will evaluate this hypothesis by examining serum PACAP levels, effect of antidepressants on PACAP levels, and gene polymorphisms of PACAP and its receptors in major depressive disorder patients. This study will enhance the investigators' understanding of PACAP's role in the etiology of depression and antidepressant treatment and will provide a basis to evaluate PACAP pathway as a potential target for diagnostics and novel antidepressants drug discovery.

Clinical Details

Official title: Assessment of PACAP-BDNF Signaling System Involvement in Etiology and Treatment of Major Depression

Study design: Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome:

Measurements of PACAP and BDNF serum levels

Analysis of genetic variants of PACAP and PAC1 coding and regulatory regions

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Men and women 18-65 age old 2. Patients with DSM-IV (or/and ICD-10) diagnosis MDD 3. Volunteers without DSM-IV (or/and ICD-10) diagnosis MDD 4. For patients with DSM-IV (or/and ICD-10) diagnosis MDD minimum 2 weeks free from benzodiazepines, mood stabilizers and neuroleptics. 5. All patients from MDD group treatment only by SSRI antidepressant medications. Exclusion Criteria: 1. MDD with Co-morbidity 2. Alcohol and drug use less than 1 month before the study

Locations and Contacts

Tirat Carmel Mental Health Center, Tirat Hacarmel 30200, Israel
Additional Information

Starting date: June 2009
Last updated: July 25, 2012

Page last updated: August 23, 2015

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