Psychotic DisordersPhase 4NCT00224302
Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
A Phase 4 study testing Duloxetine in people with Psychotic Disorders, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Duloxetine
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Nov 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depressive episode, Severity: CDSS at least 8 points or HAMD at least 15 points, indication for the treatment with duloxetine
- Lifetime diagnosis of a psychotic disorder (PANSS positive scale below 15 points)
- Age between 18 and 65,
- Informed consent
Who cannot join
- No informed consent,
- Contraindications with respect to duloxetine,
- Gravidity or missing anticonceptive safety
- Substance dependance (excluded nicotin)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Central Institute of Mental Health, Department of Psychiatry,
Mannheim, Baden-Wurttemberg, 68159
About this study
Official title: Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine
We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders
Read the detailed description
Major depressive episodes (MDE) frequently occur during the course of schizophrenic psychoses, both as as "post-psychotic" depressions, and also independently from psychotic episodes. A number of clinical studies reported the application of different antidepressive substances, such as Imipramine, Reboxetine or Venlafaxine. In general, the treatment of schizophrenic patients with antidepressive drugs can be considered as necessary and save, resulting in therapeutic guidelines of different psychiatric societies. However, since 5 to 10 % of the schizophrenic patients commit suicide, there is still much effort necessary in order to improve the treatment of affective symptoms in schizophrenic psychoses.The recently introduced antidepressive substance Duloxetine selectively inhibits as a SSNRI the reuptake of serotonine and noradrenaline from the synaptic cleft. Duloxetine was proven as antidepressive, anxiolytic and analgetic in a series of multi-centre, placebo-controlled investigations. Based on these considerations and on successful experiences in single case reports we aim to investigate the therapeutic effects of duloxetine in patients with lifetime diagnoses of the schizophrenic spectrum.
- Conditions
- Psychotic Disorders
- Being tested
- Duloxetine
- Keywords
- Schizophrenia,, schizoaffective disorder,, major depressive episode,, combination,, duloxetine
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
CDSS, HAMD, PANSS, SANS
Secondary outcomes (1)
PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Investigators
- Mathias Zink, MD, Principal investigator, Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224302
- Sponsor's protocol ID
- Duloxetine-Zink
- Status last verified
- Sep 2005
- First submitted
- 15 Sep 2005
- Last updated
- 4 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine
- ClinicalTrials.gov ID
- NCT00224302
- Acronym / sponsor ID
- Duloxetine-Zink
- Conditions
- Psychotic Disorders
- Keywords
- Schizophrenia,, schizoaffective disorder,, major depressive episode,, combination,, duloxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Sep 2005 (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.
We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders
Detailed description
Major depressive episodes (MDE) frequently occur during the course of schizophrenic psychoses, both as as "post-psychotic" depressions, and also independently from psychotic episodes. A number of clinical studies reported the application of different antidepressive substances, such as Imipramine, Reboxetine or Venlafaxine. In general, the treatment of schizophrenic patients with antidepressive drugs can be considered as necessary and save, resulting in therapeutic guidelines of different psychiatric societies. However, since 5 to 10 % of the schizophrenic patients commit suicide, there is still much effort necessary in order to improve the treatment of affective symptoms in schizophrenic psychoses.The recently introduced antidepressive substance Duloxetine selectively inhibits as a SSNRI the reuptake of serotonine and noradrenaline from the synaptic cleft. Duloxetine was proven as antidepressive, anxiolytic and analgetic in a series of multi-centre, placebo-controlled investigations. Based on these considerations and on successful experiences in single case reports we aim to investigate the therapeutic effects of duloxetine in patients with lifetime diagnoses of the schizophrenic spectrum.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major depressive episode, Severity: CDSS at least 8 points or HAMD at least 15 points, indication for the treatment with duloxetine
- Lifetime diagnosis of a psychotic disorder (PANSS positive scale below 15 points)
- Age between 18 and 65,
- Informed consent
Key exclusion criteria (4 listed)
- No informed consent,
- Contraindications with respect to duloxetine,
- Gravidity or missing anticonceptive safety
- Substance dependance (excluded nicotin)
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 |
|---|---|---|
| Duloxetine | Drug | – |
Primary outcome
CDSS, HAMD, PANSS, SANS
1 secondary outcome
PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate
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 4 Jun 2008.
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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, Mannheim, Germany
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 Duloxetine in people with Psychotic Disorders, 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 4 inclusion and 4 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 4 Jun 2008. 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?
CDSS, HAMD, PANSS, SANS. 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 4 Jun 2008.