SchizophreniaPhase 4AGOPSYCHNCT01822418
Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)
A Phase 4 study testing agomelatine in people with Schizophrenia and Schizoaffective Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder
- What is being tested?
- agomelatine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, 68159
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder
- Being tested
- agomelatine
- Keywords
- Schizophrenia, Depression, Cognition, Agomelatine, Antidepressant
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agomelatineDrug
Also called Valdoxan
Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Open-label treatment with agomelatine 25 mg/day (or 50 mg/day after week 3). Receives: Drug: agomelatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (8)
Secondary efficacy measures: Response rates
We will determine the percentage of responses (decrease of HAMD by at least 50 %)
Measured: 6 weeks and 3 months
Secondary efficacy measures: Long-term efficacy
After 12 weeks of treatment we plan to compare means of HAMD and CDSS with baseline data.
Measured: 6 weeks and 3 months
Secondary efficacy measures: Psychosocial functioning
During treatment psychosocial functioning might improve. We plan to compare means of PSP scale assessed after 6 weeks and 3 months with baseline data.
Measured: 6 weeks and 3 months
Secondary tolerability and safety measures: Psychotic symptoms
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.
Measured: 6 weeks and 3 months
Secondary tolerability and safety measures: General tolerability
The general tolerability measures include the exploration and documentation of adverse events.
Measured: 6 weeks and 3 months
Secondary tolerability and safety measures: Pharmacokinetic interactions between AGO and antipsychotic agents
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.
Measured: 6 weeks and 3 months
Secondary efficacy measures: Remission rates
We will determine the percentage of remissions (decrease of HAMD below 8)
Measured: 6 weeks and 3 months
Secondary efficacy measures: Cognitive functioning
During treatment neurocognitive deficits might improve. We plan to compare means in the MCCB assessed after 3 months with baseline data.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Sponsor
- Investigators
- Mathias Zink, MD, Principal investigator, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822418
- Sponsor's protocol ID
- 01112012
- Acronym
- AGOPSYCH
- Status last verified
- Mar 2018
- First submitted
- 11 Mar 2013
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agomelatine Treatment of Major Depressive Episodes in the Course of Schizophrenic Psychoses (AGOPSYCH)
- ClinicalTrials.gov ID
- NCT01822418
- Acronym / sponsor ID
- AGOPSYCH / 01112012
- Conditions
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder
- Keywords
- Schizophrenia, Depression, Cognition, Agomelatine, Antidepressant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- Servier
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: agomelatineOpen-label treatment with agomelatine 25 mg/day (or 50 mg/day after week 3). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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%).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| agomelatineAlso: ValdoxanAugmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day | Drug | Treatment |
Primary outcome
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.
8 secondary outcomes
Secondary efficacy measures: Response rates
Time frame: 6 weeks and 3 months
Secondary efficacy measures: Long-term efficacy
Time frame: 6 weeks and 3 months
Secondary efficacy measures: Psychosocial functioning
Time frame: 6 weeks and 3 months
Secondary tolerability and safety measures: Psychotic symptoms
Time frame: 6 weeks and 3 months
Secondary tolerability and safety measures: General tolerability
Time frame: 6 weeks and 3 months
Secondary tolerability and safety measures: Pharmacokinetic interactions between AGO and antipsychotic agents
Time frame: 6 weeks and 3 months
Secondary efficacy measures: Remission rates
Time frame: 6 weeks and 3 months
Secondary efficacy measures: Cognitive functioning
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Central Institute of Mental Health. Non-profit University hospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Zink, MD principal investigator
Central Institute of Mental Health, Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing agomelatine in people with Schizophrenia and Schizoaffective Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antidepressive efficacy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.