Completed

AGOPSYCHAgomelatine Treatment of Major Depressive Episodes in the Course of Schizophrenic Psychoses (AGOPSYCH)

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What is being tested

agomelatine

Drug
Who is being recruted

Behavior+5

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 60 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorCentral Institute of Mental Health, Mannheim
Last updated: March 8, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons: 1. AGO provides a unique pharmacological profile by combining antidepressive potency, sleep regulation and enhancement of frontocortical dopaminergic activity by 5-HT-2C-blockade. 2. AGO might exert favourable effects on cognition. 3. While pharmacokinetic interactions are generally possible, major influences on antipsychotic substances are unlikely due to metabolism by cytochrome isoenzymes CYP1A2 and CYP2C9/19. 4. AGO is characterized by a favourable range of adverse events (AE) which do not overlap with typical antipsychotic AEs such as weight gain and sexual dysfunction. Thus, the risk of additive effects seems to be small. The investigators plan to enroll 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine. As predefined primary and secondary endpoints, we are going to investigate whether AGO is able to improve MDE severity, sleep quality, general and psychosocial functioning as well as cognitive function in schizophrenia without detrimental effects on the psychotic syndrome. Moreover, we intend to monitor for pharmacokinetic interactions. The results obtained will allow designing future randomized and controlled clinical trials in order to improve the range of therapeutic options for affective and cognitive deficits in schizophrenia.

NCT01822418
Principal SponsorCentral Institute of Mental Health, Mannheim
Last updated: March 8, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsSchizophrenia Spectrum and Other Psychotic DisordersDepressionPsychotic DisordersSchizophreniaSchizophrenia, Paranoid

Criteria

6 inclusion criteria required to participate
Age between 18 and 60 years
Lifetime diagnosis of schizophrenia-spectrum disorder according to ICD-10 (F 20, F22, F23, F25)
Partial remission of psychotic positive symptoms (PANSS positive subscore <= 15 points)
Presence of an MDE according to ICD-10 criteria (HAMD17 >= 18 or CDSS-Score >= 8 points)
Show More Criteria
6 exclusion criteria prevent from participating
Addiction to alcohol
Contraindications against AGO treatment
Current abuse of THC and other illegal substances according to ICD-10
Dementia
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Open-label treatment with agomelatine 25 mg/day (or 50 mg/day after week 3).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Central Institute of Mental Health

Mannheim, GermanyOpen Central Institute of Mental Health in Google Maps
CompletedOne Study Center