Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH) (AGOPSYCH)

March 7, 2018 updated by: Central Institute of Mental Health, Mannheim

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

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. The investigators plan to test the efficacy and tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68159
        • Central Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18 and 60 years.
  2. Presence of an MDE according to ICD-10 criteria (HAMD17 ≥ 18 or CDSS-Score ≥ 8 points).
  3. Lifetime diagnosis of schizophrenia-spectrum disorder according to ICD-10 (F 20, F22, F23, F25).
  4. Partial remission of psychotic positive symptoms (PANSS positive subscore ≤ 15 points).
  5. Stable antipsychotic medication for at least 2 weeks (tolerable quantitative changes of daily dosage ≤ 25%).
  6. The patient is able to give an informed consent. In case of legal guardianship, the custodian will have to agree to the patient's participation.

Exclusion Criteria:

  1. Contraindications against AGO treatment
  2. Insufficient contraception in women of childbearing potential when sexually active.
  3. Gravidity or breastfeeding.
  4. Addiction to alcohol
  5. Current abuse of THC and other illegal substances according to ICD-10
  6. Dementia

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Open-label treatment with agomelatine 25 mg/day (or 50 mg/day after week 3).
Drug: agomelatine
Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day
Other Names:
  • Valdoxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antidepressive efficacy
Time Frame: 6 weeks
Comparison of MDE severity before and after six weeks of treatment with AGO. In order to assess the treatment success, means of HAM-D17 and CDSS scores at both baseline and week 6 will be compared within the efficacy sample (at least one application of AGO, LOCF). The primary endpoint will be tested with a two-sided student's t-test at a level of statistical significance of ≤.05.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary efficacy measures: Response rates
Time Frame: 6 weeks and 3 months
We will determine the percentage of responses (decrease of HAMD by at least 50 %)
6 weeks and 3 months
Secondary efficacy measures: Long-term efficacy
Time Frame: 6 weeks and 3 months
After 12 weeks of treatment we plan to compare means of HAMD and CDSS with baseline data.
6 weeks and 3 months
Secondary efficacy measures: Psychosocial functioning
Time Frame: 6 weeks and 3 months
During treatment psychosocial functioning might improve. We plan to compare means of PSP scale assessed after 6 weeks and 3 months with baseline data.
6 weeks and 3 months
Secondary tolerability and safety measures: Psychotic symptoms
Time Frame: 6 weeks and 3 months
The stability of the psychotic syndrome during treatment with AGO will be evaluated comparing means of PANSS after 6 weeks and 3 months with baseline.
6 weeks and 3 months
Secondary tolerability and safety measures: General tolerability
Time Frame: 6 weeks and 3 months
The general tolerability measures include the exploration and documentation of adverse events.
6 weeks and 3 months
Secondary tolerability and safety measures: Pharmacokinetic interactions between AGO and antipsychotic agents
Time Frame: 6 weeks and 3 months
Effects of AGO treatment on serum drug levels of antipsychotic agents will be evaluated by comparing the SDLs at baseline with values obtained after 6 weeks and 3 months.
6 weeks and 3 months
Secondary efficacy measures: Remission rates
Time Frame: 6 weeks and 3 months
We will determine the percentage of remissions (decrease of HAMD below 8)
6 weeks and 3 months
Secondary efficacy measures: Cognitive functioning
Time Frame: 3 months
During treatment neurocognitive deficits might improve. We plan to compare means in the MCCB assessed after 3 months with baseline data.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

Servier

Investigators

  • Principal Investigator: Mathias Zink, MD, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01112012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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