SchizophreniaNCT01936220
Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial
A study testing Continuity of specialized care, Parent groups combined with Continuity of Specialized care and Discontinuity of care, non specialised care in people with Schizophrenia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Objective: to evaluate the effectiveness of specialised and sustained intervention with or without parent groups during the initial phase of schizophrenia or related disorders on relapse prevention Methods: A three conditions randomized trial with a duration of five years Participants: 200 consecutively referred… Read more about this study
- Who is it for?
- Ages 15 to 28 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Continuity of specialized care, Parent groups combined with Continuity of Specialized care and Discontinuity of care, non specialised care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 1997to Feb 2016
- Phase
- Interventional
- 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 15 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients were eligible for the study if they: 1) met DSM-IV-Revised criteria for schizophrenia or related disorders, 2) were suffering from a first psychotic episode and 3) were living in contact with parent(s) or other relatives.
Who cannot join
- Patients with drug-related psychoses were not included.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center University of Amsterdam
Amsterdam, North Holland, 1105BC
About this study
Official title: Relapse Prevention in First Episode of Schizophrenia and Related Psychotic Disorders: a 5 Year Randomized Controlled Trial
Objective: to evaluate the effectiveness of specialised and sustained intervention with or without parent groups during the initial phase of schizophrenia or related disorders on relapse prevention
Methods: A three conditions randomized trial with a duration of five years
Read more
Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic episode of schizophrenia or related disorder
Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent groups (ST+P) and Treatment As Usual (TAU).
Outcome-measures: cumulative relapse rates and time to first relapse after first remission. Secondary outcome measure: social functioning.
Statistical analysis: cumulative relapse rates using life-table methods. The effect of the three interventions on time to first relapse after remission will be compared using Cox regression analysing intention to treat (ITT) grouping.
Read the detailed description
Evidence for optimal duration and necessary ingredients of early and sustained specialized treatment from first episode psychosis till the end of the initial phase schizophrenia is still insufficient. Randomized trials with a treatment duration of six months to two years with favorable symptomatic and psychosocial results disappeared at five year follow-up. Other studies suggest that specialized treatment should last 5 years in order to be able to prevent instead of only delaying clinical and psychosocial deteriorating.
In this study we examine both the symptomatic (relapse) and psychosocial outcome of a three armed five year randomized trial in the initial phase of schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Continuity of specialized care, Parent groups combined with Continuity of Specialized care, Discontinuity of care, non specialised care
- Keywords
- Schizophrenia, First-psychotic episode, Initial phase, Relapse prevention, Specialized treatment, Parent groups, Social functioning
- Medical subject headings
- Schizophrenia, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuity of specialized careBehavioural
Also called Relapse prevention, Specialized treatment, Maintenance antipsychotic medication
Continuity of care in treatment and professional caregiver was given during 5 year. Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).
Parent groups combined with Continuity of Specialized careBehavioural
Also called Family management as developed by Goldstein, Anderson, Falloon, Schooler and collaborators, Adaptation developed for parents of first psychotic episode patients as described in an earlier study of our group.
Approximately fifty parent group therapy sessions will be held in a flexible way over a 60 month period. Each parent group was run by two experienced family therapists.
Discontinuity of care, non specialised careBehavioural
Also called Standard relapse prevention
Standard Treatment as usual (TU) was provided during 5 years by local mental health care professionals situated nearby the domicile of patients. TU had comparable treatment targets as ST but was not provided by treatment staff specialized in early intervention in schizophrenia or related disorders. However, TU was (like ST) sustained and dedicated to prevent psychotic relapse and improve social functioning.
| Study group | Role | What they receive |
|---|---|---|
| Continuity of specialized care | Experimental | Continuity of specialized inpatient and outpatient care (relapse prevention) Receives: Behavioral: Continuity of specialized care |
| Continuity of specialized care and parent groups | Experimental | Continuity of specialized care combined with Parent groups Receives: Behavioral: Continuity of specialized care; Behavioral: Parent groups combined with Continuity of Specialized care |
| Treatment as usual | Active comparator | Discontinuity of care, relapse prevention as usual Receives: Behavioral: Discontinuity of care, non specialised care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychotic relapse
Participants will be followed for the duration of the 5 year outpatient treatment of the trial. During the trial the timing and number of psychotic relapses of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial.
Trained interviewers not involved in clinical treatment of patients will elicit with the LCS detailed information of symptoms, signs and treatment from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in symptomatology since the last interview. All details will be fitted in a schedule with 6 months intervals.
Measured: at year 1, year 3 and year 5
Secondary outcomes (1)
Change in Social functioning
During the duration of the 5 year outpatient treatment of the trial social functioning of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial.
Detailed information of social functioning in work, study, school and relations will be elicited from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in functioning since the last interview.All details will be fitted in a schedule with 6 months.
Measured: at year 1, year 3 and year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startSep 1997
- Primary completionFeb 2007
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Donald H. Linszen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Don Linszen, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936220
- Sponsor's protocol ID
- Grant 28-1241-2
- Status last verified
- Sep 2013
- First submitted
- 23 Aug 2013
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Linszen D, Dingemans P, Lenior M. Early intervention and a five year follow up in young adults with a short duration of untreated psychosis: ethical implications. Schizophr Res. 2001 Aug 1;51(1):55-61. doi: 10.1016/s0920-9964(01)00239-0.
PubMed 11479066Linszen D, Lenior M, De Haan L, Dingemans P, Gersons B. Early intervention, untreated psychosis and the course of early schizophrenia. Br J Psychiatry Suppl. 1998;172(33):84-9.
PubMed 9764132Linszen D, Dingemans P, Van der Does JW, Nugter A, Scholte P, Lenior R, Goldstein MJ. Treatment, expressed emotion and relapse in recent onset schizophrenic disorders. Psychol Med. 1996 Mar;26(2):333-42. doi: 10.1017/s0033291700034723.
PubMed 8685289Lenior ME, Dingemans PM, Linszen DH, de Haan L, Schene AH. Social functioning and the course of early-onset schizophrenia: five-year follow-up of a psychosocial intervention. Br J Psychiatry. 2001 Jul;179:53-8. doi: 10.1192/bjp.179.1.53.
PubMed 11435269
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse Prevention in First Episode of Schizophrenia and Related Psychotic Disorders: a 5 Year Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01936220
- Acronym / sponsor ID
- Grant 28-1241-2
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, First-psychotic episode, Initial phase, Relapse prevention, Specialized treatment, Parent groups, Social functioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Sep 1997
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2016 (estimated)
- First posted
- 6 Sep 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.
Objective: to evaluate the effectiveness of specialised and sustained intervention with or without parent groups during the initial phase of schizophrenia or related disorders on relapse prevention
Methods: A three conditions randomized trial with a duration of five years
Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic episode of schizophrenia or related disorder
Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent groups (ST+P) and Treatment As Usual (TAU).
Outcome-measures: cumulative relapse rates and time to first relapse after first remission. Secondary outcome measure: social functioning.
Statistical analysis: cumulative relapse rates using life-table methods. The effect of the three interventions on time to first relapse after remission will be compared using Cox regression analysing intention to treat (ITT) grouping.
Detailed description
Evidence for optimal duration and necessary ingredients of early and sustained specialized treatment from first episode psychosis till the end of the initial phase schizophrenia is still insufficient. Randomized trials with a treatment duration of six months to two years with favorable symptomatic and psychosocial results disappeared at five year follow-up. Other studies suggest that specialized treatment should last 5 years in order to be able to prevent instead of only delaying clinical and psychosocial deteriorating.
In this study we examine both the symptomatic (relapse) and psychosocial outcome of a three armed five year randomized trial in the initial phase of schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuity of specialized care | Experimental | Behavioral: Continuity of specialized careContinuity of specialized inpatient and outpatient care (relapse prevention) |
| Continuity of specialized care and parent groups | Experimental | Behavioral: Continuity of specialized care, Behavioral: Parent groups combined with Continuity of Specialized careContinuity of specialized care combined with Parent groups |
| Treatment as usual | Active comparator | Behavioral: Discontinuity of care, non specialised careDiscontinuity of care, relapse prevention as usual |
Who may qualify
- Ages
- 15 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients were eligible for the study if they: 1) met DSM-IV-Revised criteria for schizophrenia or related disorders, 2) were suffering from a first psychotic episode and 3) were living in contact with parent(s) or other relatives.
Key exclusion criteria (1 listed)
- Patients with drug-related psychoses were not included.
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 |
|---|---|---|
| Continuity of specialized careAlso: Relapse prevention, Specialized treatment, Maintenance antipsychotic medicationContinuity of care in treatment and professional caregiver was given during 5 year. Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education). | Behavioural | Continuity of specialized care, Continuity of specialized care and parent groups |
| Parent groups combined with Continuity of Specialized careAlso: Family management as developed by Goldstein, Anderson, Falloon, Schooler and collaborators, Adaptation developed for parents of first psychotic episode patients as described in an earlier study of our group.Approximately fifty parent group therapy sessions will be held in a flexible way over a 60 month period. Each parent group was run by two experienced family therapists. | Behavioural | Continuity of specialized care and parent groups |
| Discontinuity of care, non specialised careAlso: Standard relapse preventionStandard Treatment as usual (TU) was provided during 5 years by local mental health care professionals situated nearby the domicile of patients. TU had comparable treatment targets as ST but was not provided by treatment staff specialized in early intervention in schizophrenia or related disorders. However, TU was (like ST) sustained and dedicated to prevent psychotic relapse and improve social functioning. | Behavioural | Treatment as usual |
Primary outcome
Change in Psychotic relapse
Time frame: at year 1, year 3 and year 5
Participants will be followed for the duration of the 5 year outpatient treatment of the trial. During the trial the timing and number of psychotic relapses of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial. Trained interviewers not involved in clinical treatment of patients will elicit with the LCS detailed information of symptoms, signs and treatment from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in symptomatology since the last interview. All details will be fitted in a schedule with 6 months intervals.
1 secondary outcome
Change in Social functioning
Time frame: at year 1, year 3 and year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
- Background: PubMed 11479066Linszen D, Dingemans P, Lenior M. Early intervention and a five year follow up in young adults with a short duration of untreated psychosis: ethical implications. Schizophr Res. 2001 Aug 1;51(1):55-61. doi: 10.1016/s0920-9964(01)00239-0.
- Background: PubMed 9764132Linszen D, Lenior M, De Haan L, Dingemans P, Gersons B. Early intervention, untreated psychosis and the course of early schizophrenia. Br J Psychiatry Suppl. 1998;172(33):84-9.
- Background: PubMed 8685289Linszen D, Dingemans P, Van der Does JW, Nugter A, Scholte P, Lenior R, Goldstein MJ. Treatment, expressed emotion and relapse in recent onset schizophrenic disorders. Psychol Med. 1996 Mar;26(2):333-42. doi: 10.1017/s0033291700034723.
- Background: PubMed 11435269Lenior ME, Dingemans PM, Linszen DH, de Haan L, Schene AH. Social functioning and the course of early-onset schizophrenia: five-year follow-up of a psychosocial intervention. Br J Psychiatry. 2001 Jul;179:53-8. doi: 10.1192/bjp.179.1.53.
- The RAISE Early Treatment Program (ETP), led by John Kane, M.D., of the Feinstein Institute for Medical Research in Manhasset, NY, is conducting a similar RCT with the same population and a comparable design.Link provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Don Linszen, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuity of specialized care, Parent groups combined with Continuity of Specialized care and Discontinuity of care, non specialised care in people with Schizophrenia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Sep 2013. 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 Netherlands. 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?
Results are not available in the source record.
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?
Change in Psychotic relapse (time frame: at year 1, year 3 and year 5). 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 NCT01936220, which also lists 4 linked publications.
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 6 Sep 2013.