Schizophrenia4DNCT00782899
Four Dimensions in Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca at 65 sites in Spain.
Trial summary
Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The primary objective is to asses evolution of subjective well-being and depressive symptoms in schizophrenic patients for six months after an… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 320 participants
- Where
- 65 sitesSpain
- Study dates
- Oct 2008to Sep 2009
- Phase
- Observational
- 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
Study population: Schizophrenic patients with a acute episode or worsening of clinical status treated in outpatients clinics. Defined acute episode or worsening as clinical status that need a significant change in the therapeutic plan.
Who may be able to join
- Provision of written inform consent
- Diagnosed of Schizophrenia of Schizoaffective Disorder based on DSM-IV-TR
- With an acute episode or worsening of clinical status. Defined as change in clinical status that need a significant change in therapeutic plan.
- Able to understand and comply with requirements of the study
Who cannot join
- Mental retardation
- Unstable somatic disease, that is not receiving adequate treatment, based on investigator opinion.
- To have been recruited in a clinical trial in the last 4 weeks
- To have planned the inclusion in a clinical trial during the follow-up of this study
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
Spain65 sites
Research Site
Adaia, Valencia
Research Site
Adeje, Tenerife
Research Site
Alcalá de Guadaira, Sevilla
Research Site
Alcalá de Henares, Madrid
Research Site
Alcalá la Real, Jaen
Research Site
Alcoy, Alicante
Research Site
Alicante, Alicante
Research Site
Almansa, Albacete
Research Site
Aranda de Duero, Burgos
Research Site
Arriondas, Principality of Asturias
Research Site
Avilés, Principality of Asturias
Research Site
Banaderos, Las Palmas
Research Site
Barcelona, Barcelona
Research Site
Béjar, Salamanca
Research Site
Benidorm, Alicante
Research Site
Bilbao, Vizcaya
Research Site
Cáceres, Caceres
Research Site
Caravaca de La Cruz, Murcia
Research Site
Cartagena, Murcia
Research Site
Catarroja, Valencia
Research Site
Colmenar Viejo, Madrid
Research Site
Donostia / San Sebastian, Guipuzcoa
Research Site
Écija, Sevilla
Research Site
El Ejido, Almeria
Research Site
El Hospitalet de Llobregat, Barcelona
Research Site
El Vendrell, Tarragona
Research Site
Elizondo, Navarre
Research Site
Errenteria, Guipuzcoa
Research Site
Fuenlabrada, Madrid
Research Site
Gavà, Barcelona
Research Site
Getafe, Madrid
Research Site
Gijón, Principality of Asturias
Research Site
Leganés, Madrid
Research Site
Linares, Jaen
Research Site
Logroño, La Rioja
Research Site
Madrid, Madrid
Research Site
Málaga, Malaga
Research Site
Maliaño, Cantabria
Research Site
Manacor, Balearic Islands
Research Site
Manresa, Barcelona
Research Site
Mataró, Barcelona
Research Site
Mislata, Valencia
Research Site
Montforte, Lugo
Research Site
Oviedo, Principality of Asturias
Research Site
Palma de Mallorca, Balearic Islands
Research Site
Reus, Tarragona
Research Site
Roquetas de Mar, Almeria
Research Site
Sabadell, Barcelona
Research Site
Salamanca, Salamanca
Research Site
San Cristóbal de La Laguna, Tenerife
Research Site
Sant Feliu de Llobregat, Barcelona
Research Site
Santa Coloma de Gramanet, Barcelona
Research Site
Santa Cruz de Tenerife, Tenerife
Research Site
Seville, Sevilla
Research Site
Soria, Soria
Research Site
Terrassa, Barcelona
Research Site
Toledo, Toledo
Research Site
Valencia, Valencia
Research Site
Valladolid, Valladolid
Research Site
Vélez-Málaga, Malaga
Research Site
Vigo, Pontevedra
Research Site
Vinaròs, Castellon
Research Site
Vitoria-Gasteiz, Alava
Research Site
Zafra, Badajoz
Research Site
Zaragoza, Zaragoza
About this study
Official title: Prospective Observational Study About Progress of Subjective Well-being Sensation in Schizophrenic Patients
Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The primary objective is to asses evolution of subjective well-being and depressive symptoms in schizophrenic patients for six months after an acute episode treated in outpatient psychiatric units. The primary endpoint is: Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline. Secondary objectives include: To evaluate the relationship between subjective well-being and psychopathology, subjective clinical global impression, adverse events and compliance of treatment. Also to compare the clinical global impression of psychiatrist and patient. In addiction to know the clinical, social and demographic factors involve in the subjective well-being and patient clinical global impression.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, subjective well-being, depressive symptoms, schizophrenia course
- Medical subject headings
- Schizophrenia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Schizophrenic patients with a acute episode treated in outpatients clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline
Measured: Months: 0, 1, 3 and 6
Secondary outcomes (3)
Patient Clinical Impression
Measured: Months: 0, 1, 3 and 6
Clinical evaluation and social performance
Measured: Months: 0, 1, 3 and 6
Adverse events reported by patients
Measured: Months: 0, 1, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionSep 2009
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782899
- Sponsor's protocol ID
- NIS-NES-DUM-2008/2
- Acronym
- 4D
- Status last verified
- Dec 2009
- First submitted
- 30 Oct 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study About Progress of Subjective Well-being Sensation in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00782899
- Acronym / sponsor ID
- 4D / NIS-NES-DUM-2008/2
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, subjective well-being, depressive symptoms, schizophrenia course
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 31 Oct 2008 (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.
Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The primary objective is to asses evolution of subjective well-being and depressive symptoms in schizophrenic patients for six months after an acute episode treated in outpatient psychiatric units. The primary endpoint is: Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline. Secondary objectives include: To evaluate the relationship between subjective well-being and psychopathology, subjective clinical global impression, adverse events and compliance of treatment. Also to compare the clinical global impression of psychiatrist and patient. In addiction to know the clinical, social and demographic factors involve in the subjective well-being and patient clinical global impression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Schizophrenic patients with a acute episode treated in outpatients clinics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Schizophrenic patients with a acute episode or worsening of clinical status treated in outpatients clinics. Defined acute episode or worsening as clinical status that need a significant change in the therapeutic plan.
Key inclusion criteria (4 listed)
- Provision of written inform consent
- Diagnosed of Schizophrenia of Schizoaffective Disorder based on DSM-IV-TR
- With an acute episode or worsening of clinical status. Defined as change in clinical status that need a significant change in therapeutic plan.
- Able to understand and comply with requirements of the study
Key exclusion criteria (4 listed)
- Mental retardation
- Unstable somatic disease, that is not receiving adequate treatment, based on investigator opinion.
- To have been recruited in a clinical trial in the last 4 weeks
- To have planned the inclusion in a clinical trial during the follow-up of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline
Time frame: Months: 0, 1, 3 and 6
3 secondary outcomes
Patient Clinical Impression
Time frame: Months: 0, 1, 3 and 6
Clinical evaluation and social performance
Time frame: Months: 0, 1, 3 and 6
Adverse events reported by patients
Time frame: Months: 0, 1, 3 and 6
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 10 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by AstraZeneca at 65 sites in Spain.
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 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Spain. 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.
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?
Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline (time frame: Months: 0, 1, 3 and 6). 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 10 Dec 2010.