Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH) (AGOPSYCH)
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|ClinicalTrials.gov Identifier: NCT01822418|
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Delusional Disorder||Drug: agomelatine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Agomelatine Treatment of Major Depressive Episodes in the Course of Schizophrenic Psychoses (AGOPSYCH)|
|Study Start Date :||January 2013|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
Open-label treatment with agomelatine 25 mg/day (or 50 mg/day after week 3).
Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day
Other Name: Valdoxan
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822418
|Central Institute of Mental Health|
|Mannheim, Baden-Württemberg, Germany, 68159|
|Principal Investigator:||Mathias Zink, MD||Central Institute of Mental Health, Department of Psychiatry and Psychotherapy|