Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to identify evidence-based guidelines for treating major depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients. To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify the shared biological mechanisms between mood, immune and metabolism homeostasis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Intranasal Insulin on Depressive Symptoms in Major Depressive Disorder

NCT00570050

Major Depressive Disorder

COMPLETED PHASE3

Objective Diagnostic Markers and Personalized Intervention in MDD Patients

NCT02023567

Depressive Disorder, Major

UNKNOWN NA

Research on the Biological Mechanism of the Efficacy of Psychotherapy for Depression Based on the fNIRS

NCT05927129

Depressive Disorder

UNKNOWN NA

Early Prediction of Fluoxetine Response

NCT01075529

Major Depressive Disorder

COMPLETED PHASE4

Longitudinal Study of People Presenting for First Treatment of a Mood Disorder

NCT01529905

Major Depression Bipolar Disorder

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The prevalence of insulin resistance did not significantly differ among the healthy controls and drug-naïve MDD patients before and after antidepressant treatment. Meanwhile, the current study indicated that antidepressants might affect insulin secretion independently of the therapeutic effects on MDD. Therapeutic strategies considering both treatment effectiveness and glucose-insulin homeostasis in MDD patients are necessary.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fluoxetine + Valsartan

The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg.

Add-on treatment to 40 mg per day of valsartan

Group Type EXPERIMENTAL

Fluoxetine + Valsartan

Intervention Type DRUG

The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.

Fluoxetine + Placebo

The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg.

Add-on treatment to placebo

Group Type ACTIVE_COMPARATOR

Fluoxetine + Placebo

Intervention Type DRUG

The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluoxetine + Valsartan

The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.

Intervention Type DRUG

Fluoxetine + Placebo

The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prozac Diovan Prozac

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 16-65 years old
* Signed informed consent by patient or legal representative
* Hamilton Rating Scale for Depression (HDRS) scores ≥ 16
* A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry

Exclusion Criteria

* Monoamine oxidase inhibitor or antidepressant treatment prior to entering the study
* A DSM-IV diagnosis of substance abuse within the past three months
* An organic mental disease, mental retardation or dementia
* A serious surgical condition or physical illness
* Patients who were pregnant or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No