The Phosphodiesterase Inhibitor Tadalafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients

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

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-12-31

Brief Summary

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Antidepressant-like effects of tadalafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with tadalafil was shown to be PKG-dependent and lead to increased expression of cGMP, pCREB, BDNF and VGF in the hippocampus and prefrontal cortex (PFC), brain areas relevant to mood disorders pathophysiology. Low-dose tadalafil improved both depressive symptoms in patients with erectile dysfunction.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tadalafil

Group Type EXPERIMENTAL

Tadalafil 5Mg Tab

Intervention Type DRUG

Tadalafil 5Mg Tab plus Fluoxetine 20 mg capsule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Tab plus Fluoxetine 20 mg capsule

Interventions

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Tadalafil 5Mg Tab

Tadalafil 5Mg Tab plus Fluoxetine 20 mg capsule

Intervention Type DRUG

Placebo

Placebo Tab plus Fluoxetine 20 mg capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).

Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria

Patients with bipolar I or bipolar II disorder Patients with personality disorders Patients with eating disorders Patients with substance dependence or abuse Patients with concurrent active medical condition Patients with history of seizures Patients with history of receiving Electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females Cardiovascular disorders Severe renal impairment: creatinine clearance of ≤ 25 ml/min Moderate or severe hepatic impairment

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No