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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

NCT ID: NCT00944996

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depression

Keywords

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PACAP (Pituitary Adenylate Cyclase Activating Polypeptide) Major Depression Receptors Gene polymorphism PACAP signaling system Etiology of major depression Mechanism of antidepressants action PACAP receptors gene polymorphism Pathogenesis of major depression Responsiveness to the antidepressant drugs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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antidepressant

Group Type ACTIVE_COMPARATOR

SSRI; SNRI; TCA

Intervention Type DRUG

Tablets or Pills, 1 or 2 per day, more than 2 month

Healthy volunteers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SSRI; SNRI; TCA

Tablets or Pills, 1 or 2 per day, more than 2 month

Intervention Type DRUG

Other Intervention Names

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paroxetine, fluoxetine, sertraline, escitalopram, citalopram mirtrazapine, venlafaxine anafranil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Ariel University

OTHER

Sponsor Role collaborator

The Nazareth Hospital, Israel

OTHER

Sponsor Role collaborator

Tirat Carmel Mental Health Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anatoly Dr. Kreinin

Director of Psychiatric Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anatoly Kreinin, MD, PhD

Role: STUDY_CHAIR

The Bruce and Ruth Rappaport Faculty of Medicine, Technion, Haifa

Albert Pinhasov, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Molecular Biology at Ariel University Center

Leon Raskin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Kamal Farhat, MD

Role: PRINCIPAL_INVESTIGATOR

The Nazareth Hospital-EMMS

Joseph Farah, MD

Role: PRINCIPAL_INVESTIGATOR

The Nazareth Hospital-EMMS

Klaudia Rybalksy, MD

Role: PRINCIPAL_INVESTIGATOR

The Nazareth Hospital-EMMS

Locations

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Tirat Carmel Mental Health Center

Tirat Hacarmel, , Israel

Site Status

Countries

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Israel

Other Identifiers

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920080174

Identifier Type: -

Identifier Source: secondary_id

040-2008

Identifier Type: -

Identifier Source: secondary_id

akparl08

Identifier Type: -

Identifier Source: org_study_id