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SchizophreniaPhase 4NCT00511277

Efficacy and Safety of Quetiapine in Treating Affective Symptoms of Patients With First-episode psychosis-a Pilot Study

A Phase 4 study testing Seroquel® in people with Schizophrenia, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is: To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in treating depressive symptoms. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Schizophrenia
What is being tested?
Seroquel®
Type of treatment
Pill or oral medicine
How many people
60 participants
Where
1 siteGermany
Study dates
Aug 2007to Apr 2011
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 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • All patients who meet the following inclusion criteria are eligible to participate in the study:
  • male and female patients with first-episode schizophrenia (based on ICD-10 criteria)
  • in- and out-patients
  • age between 18 and 45
  • verbal IQ 85
  • given written informed consent

Who cannot join

  • Patients who meet one or more of the following exclusion criteria cannot participate in the study:
  • Other Psychiatric disorders not in full remission, concomitant organic mental disorder or mental retardation
  • Patients who, in the investigators judgement, pose an imminent risk of suicide or a danger to self or others
  • Hamilton Depression Rating Scale<7 points
  • Female patients who are pregnant, lactating or at risk of pregnancy
  • Female patients who are not using a highly effective method of birth control. A highly effective method of birth control is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implantants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under investigation and its potential effect on the contraception must be addressed.
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  • history of idiopathic orthostatic hypotension, or condition that would predispose to (dehydration, hypovolaemia)
  • Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B and C, via blood or other body fluids
  • history of non-compliance as judged by the investigator
  • Patients with substance dependence. A urine drug screen will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets the DSM-IV criteria for substance dependence
  • Patients with known diabetes mellitus or impaired glucose tolerance, especially a patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
  • unstable DM defined as enrollment glycosylated hemoglobin (HbA1c)>8.5%
  • patients admitted to hospital for treatment of DM or DM related illness in past 12 weeks
  • patients not under physicians care for DM
  • physicians responsible for patient´s DM care has not indicated that patient´s DM is controlled
  • physician responsible for patient´s DM care has not approved patient´s participation in the study
  • patient has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to randomization. (For thiazolidinediones (glitazones) this period should not be less than 8 weeks)
  • patients taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks.
  • Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
  • ECG considered to show clinical significant abnormalities at enrolment as determined by a cardiologist
  • Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzyme within 2 weeks prior to randomization (e.g. inducers: phenytoin, carbamazepine, phenobarbital, rifampicin, rifabutin, glucocorticoids, thioridazine and St. Johns´wort (=Johanniskraut) and inhibitors: ketaconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, fluvoxamine, nefazodone, troleandomycin, indinavir, nelfinavir and saquinavir).
  • patients with insufficient knowledge of the German language
  • A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range and the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism
  • Any serious and unstable somatic illness (e.g. malignant tumor, severe cardiovascular disease, etc.) that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect study medication. If relevant medical findings are obtained during the examination, it is at the physician's discretion to initiate additional examinations (e.g. lab testing, ECG). If medically indicated examinations have already been carried out, the results should not be older than two weeks at the time of the screening visit. The patient can only participate in the study if all study results are within the normal range or the examiner has determined a deviation as clinically irrelevant. This should be clearly documented in the CRF.
  • Participation in another drug trial within 4 weeks prior to enrolment into this study or longer in accordance with local requirements

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Psychiatry and Psychotherapy, GEORG-AUGUST-UNIVERSITY GÖTTINGEN

    Göttingen

Other trials in Germany

About this study

Official title: Single-arm, Open-label and Multicenter Phase IV Study: Efficacy and Safety of Quetiapine in Treating Affective Symptoms of Patients With First-episode Psychosis - a Pilot Study

The purpose of this study is:

To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in treating depressive symptoms.

To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in mania-like symptoms and to evaluate the general efficacy in psychopathology as well as the safety and tolerability of quetiapine.

Read the detailed description

Affective symptoms, in particular depressive symptoms are prevalent in up to 60% of all patients with schizophrenia. However, it is still uncertain whether depressive symptoms have a prognostic value, having previously been associated with both favorable and poor outcome. In addition, treatment of affective symptoms in patients with schizophrenia is difficult. There is some evidence that atypical antipsychotics such as quetiapine may contribute not only to a reduction in psychotic symptoms but also that these agents may produce an antidepressant effect in schizophrenia and may reduce suicidality. Most of these studies suffer from methodological limitations as the efficacy on affective symptoms has not been the primary target parameter. Concerning the prevalence of affective symptoms in first-episode psychosis knowledge is still poor. This is why we have developed a study design for a pilot-study on 60 patients with first-episode schizophrenia aiming to demonstrate that a treatment with quetiapine over the period of 6 months shows clinical efficacy on affective, particularly depressive symptoms

Conditions
Schizophrenia
Being tested
Seroquel®
Keywords
quetiapine, schizophrenia, first-episode psychosis, depression, psychopathology
Medical subject headings
Schizophrenia, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seroquel®Drug

    Also called Quetiapine

    dosage form: oral, dosage: 300-800mg/d, frequency: twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the Hamilton Depression Rating Scale (HAMDS) from Baseline to Endpoint

    Measured: treatment for six months

Secondary outcomes (1)

  1. Changes in the Young Mania Rating Scale,Changes in the Positive and Negative Syndrome Scale,Changes in the Clinical Global Impression Scale(CGI,Changes in the self assessment of depressive symptoms(Beck Depression Inventory) from Baseline to Endpoint.

    Measured: for six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionOct 2010
  4. Study completionApr 2011

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00511277
Sponsor's protocol ID
D1449L00016
Status last verified
Jun 2011
First submitted
2 Aug 2007
Last updated
21 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Seroquel® in people with Schizophrenia, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH 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 25 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 21 Jun 2011. 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?

Changes in the Hamilton Depression Rating Scale (HAMDS) from Baseline to Endpoint (time frame: treatment for six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00511277.

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 21 Jun 2011.

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