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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Central Institute of Mental Health, Mannheim.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01822418
First Posted: April 2, 2013
Last Update Posted: April 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Servier
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim
March 11, 2013
April 2, 2013
April 2, 2013
January 2013
December 2014   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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 %)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Secondary efficacy measures: Remission rates [ Time Frame: 6 weeks and 3 months ]
    We will determine the percentage of remissions (decrease of HAMD below 8)
  • 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.
Same as current
Not Provided
Not Provided
 
Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)
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.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizophrenia-spectrum-disorders
Drug: agomelatine
n.a.
Other Name: Valdoxan
Experimental: Treatment
Open-label treatment with agomelatine 25 mg/day (or 50 mg/day after week 3).
Intervention: Drug: agomelatine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
27
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01822418
01112012
Yes
Not Provided
Not Provided
Central Institute of Mental Health, Mannheim
Central Institute of Mental Health, Mannheim
Servier
Principal Investigator: Mathias Zink, MD Central Institute of Mental Health, Department of Psychiatry and Psychotherapy
Central Institute of Mental Health, Mannheim
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP