NCT01822418

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2013

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

March 11, 2013

Last Update Submit

March 7, 2018

Conditions

SchizophreniaSchizoaffective DisorderDelusional Disorder

Keywords

SchizophreniaDepressionCognitionAgomelatineAntidepressant

Outcome Measures

Primary Outcomes (1)

  • Antidepressive efficacy

    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 Outcomes (8)

  • Secondary efficacy measures: Response rates

    6 weeks and 3 months

  • Secondary efficacy measures: Long-term efficacy

    6 weeks and 3 months

  • Secondary efficacy measures: Psychosocial functioning

    6 weeks and 3 months

  • Secondary tolerability and safety measures: Psychotic symptoms

    6 weeks and 3 months

  • Secondary tolerability and safety measures: General tolerability

    6 weeks and 3 months

  • +3 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: agomelatine

Interventions

agomelatineDRUG

Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day

Also known as: Valdoxan
Treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60 years.
  • Presence of an MDE according to ICD-10 criteria (HAMD17 ≥ 18 or CDSS-Score ≥ 8 points).
  • 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).
  • Stable antipsychotic medication for at least 2 weeks (tolerable quantitative changes of daily dosage ≤ 25%).
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSchizophrenia, ParanoidDepression

Interventions

agomelatine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Mathias Zink, MD

    Central Institute of Mental Health, Department of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

April 2, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 8, 2018

Record last verified: 2018-03

Locations

DE(1)