SchizophreniaPhase 1/2NCT00392249
Supervised Treatment of Schizophrenia, a Randomized Controlled Trial.
A Phase 1/2 study testing Supervised Treatment of Schizophrenia by a family member in people with Schizophrenia and Schizoaffective Disorders, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Patients suffering from Schizophrenia and their families often suffer from poor care because of ignorance about the disorder especially in economically developing countries. Although antipsychotic medication is effective in reducing relapse rate, 30-40 percent of patients relapse within one year and 40-60 percent… Read more about this study
- Who is it for?
- Ages 17 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorders
- What is being tested?
- Supervised Treatment of Schizophrenia by a family member
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2006to Sep 2008
- Phase
- Phase 1/2
- 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 17 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder based on the ICD-10 criteria for schizophrenia.
- Patients requiring treatment in outpatients
- Residence in Peshawar district
- Patient living with relative(care giver) for at least six months.
Who cannot join
- Evidence of organic mental disorder
- Evidence of mental retardation
- Severe drug dependence requiring inpatient treatment and/or detoxification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supervised Treatment in Outpatients for Schizophrenia (STOPS)Versus Treatment as Usual in Outpatients, a Randomized Controlled Trial.
Patients suffering from Schizophrenia and their families often suffer from poor care because of ignorance about the disorder especially in economically developing countries. Although antipsychotic medication is effective in reducing relapse rate, 30-40 percent of patients relapse within one year and 40-60 percent relapse within 2 years after discharge from 1st hospitalization even if they are receiving maintenance medication.
Although antipsychotic medications are the mainstay of the treatment for schizophrenia, patients with schizophrenia benefit more from combined use of antipsychotic drugs and psychosocial treatment than pharmacotherapy alone in delaying or preventing relapse or reducing hospital days. It is also less costly than standard treatment and suitable for psychiatric rehabilitation.
Read more
Although there are now a number of studies from western countries and a randomized controlled trial from china which have led to increase enthusiasm about psychosocial treatment for schizophrenia but question remains about comparative benefit of treatment methods and additional methods of multiple treatment. In developing countries there is need for further studies in which integrated treatment of pharmaco-therapy and psycho-education is instituted and compared with treatment as usual.
Realizing the need for maintaining the compliance and continuity of treatment, department of psychiatry has started a program called Supervised Treatment of Outpatient Schizophrenia. This study aims to evaluate the effectiveness of Supervised Treatment versus the usual care provided in the outpatient.
Read the detailed description
Introduction:
Schizophrenic patients and their families often suffer from poor care because of ignorance about the disorder1, especially in economically developing countries. Although many patients of schizophrenia respond well to antipsychotic treatment, the risk of subsequent relapses is generally high2, 40-60 percent relapse within 2 years after discharge from 1st hospitalization is observed even if they are receiving maintenance medication1.
Also non-compliance is quite common in patients with schizophrenia like any other illness, and it should be addressed3 because noncompliance and aggression risk profile symptoms are positively correlated to hospitalization4.
Non-compliance is also common in Pakistan like any other society. The commonest reasons for non-compliance are unawareness of the benefits of treatment, non affordability of drugs, physical side effects, no awareness given by the doctor and unfriendly attitude of doctors5.
Educational therapy both for patient and family led to significant psychopathological improvement at post-treatment and at follow-up.6 The recent trend of family intervention produced many models. One long-term family based intervention reduced the risk of psychotic relapse to about the half within the first two years. These methods also shorten hospital stays, improve compliance with medication, patients' social functioning and relatives' well-being, and they seem to be cost-effective.7 Definitive relationship exists between compliance and the economic costs of schizophrenia as lower rates of compliance lead to higher costs of treating schizophrenia8.
Family education on schizophrenia in China was effective in improving knowledge and promoting improvement in patients' symptoms9. A largest randomized controlled trial from china10 have led to increase enthusiasm about psychosocial treatment for schizophrenia but question remains about comparative benefit of treatment methods and additional methods of multiple treatment11.
Mostly research done on role of psychosocial-education in schizophrenia is from developed countries but no work has been done yet in developing country like Pakistan even Subcontinent having a different cultural background. Realizing the need for maintaining the compliance and continuity of treatment, I have designed a study program called Supervised Treatment of Outpatient Schizophrenia. This study aims to evaluate the effectiveness of Supervised Treatment versus the usual care provided in the outpatient.
- Conditions
- Schizophrenia, Schizoaffective Disorders
- Being tested
- Supervised Treatment of Schizophrenia by a family member
- Keywords
- Schizophrenia, Drug adherence
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Treatment of Schizophrenia by a family memberBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the compliance in patients suffering from schizophrenia with Supervised Treatment in Outpatients for Schizophrenia with Treatment As Usual (TAU, control group)
Secondary outcomes (1)
To compare the effectiveness of Supervised Treatment in Outpatients of Schizophrenia with Treatment As Usual (TAU, control group) in preventing relapse and rehospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2008 (estimated)
- Study completionSep 2008 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Reading Hospital, Pakistan
- Sponsor type
- Other government
- Collaborators
- GTZ Pakistan (German Technical Cooperation)
- Investigators
- Saeed Farooq, MCPS,FCPS, Principal investigator, • Associate Professor, and Head Department of Psychiatry, Postgraduate Medical Institute, (P.G.M.I) Hayat Abad Medical Complex, Peshawar, Pakistan and consultant Psychiatrist Lady Reading Hospital, Peshawar. Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392249
- Sponsor's protocol ID
- PGMILRH 01
- Status last verified
- Feb 2008
- First submitted
- 24 Oct 2006
- Last updated
- 27 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Treatment in Outpatients for Schizophrenia (STOPS)Versus Treatment as Usual in Outpatients, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00392249
- Acronym / sponsor ID
- PGMILRH 01
- Conditions
- Schizophrenia, Schizoaffective Disorders
- Keywords
- Schizophrenia, Drug adherence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Lady Reading Hospital, PakistanOther government
- Collaborators
- GTZ Pakistan (German Technical Cooperation)
- Study start
- Nov 2006
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 25 Oct 2006 (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.
Patients suffering from Schizophrenia and their families often suffer from poor care because of ignorance about the disorder especially in economically developing countries. Although antipsychotic medication is effective in reducing relapse rate, 30-40 percent of patients relapse within one year and 40-60 percent relapse within 2 years after discharge from 1st hospitalization even if they are receiving maintenance medication.
Although antipsychotic medications are the mainstay of the treatment for schizophrenia, patients with schizophrenia benefit more from combined use of antipsychotic drugs and psychosocial treatment than pharmacotherapy alone in delaying or preventing relapse or reducing hospital days. It is also less costly than standard treatment and suitable for psychiatric rehabilitation.
Although there are now a number of studies from western countries and a randomized controlled trial from china which have led to increase enthusiasm about psychosocial treatment for schizophrenia but question remains about comparative benefit of treatment methods and additional methods of multiple treatment. In developing countries there is need for further studies in which integrated treatment of pharmaco-therapy and psycho-education is instituted and compared with treatment as usual.
Realizing the need for maintaining the compliance and continuity of treatment, department of psychiatry has started a program called Supervised Treatment of Outpatient Schizophrenia. This study aims to evaluate the effectiveness of Supervised Treatment versus the usual care provided in the outpatient.
Detailed description
Introduction:
Schizophrenic patients and their families often suffer from poor care because of ignorance about the disorder1, especially in economically developing countries. Although many patients of schizophrenia respond well to antipsychotic treatment, the risk of subsequent relapses is generally high2, 40-60 percent relapse within 2 years after discharge from 1st hospitalization is observed even if they are receiving maintenance medication1.
Also non-compliance is quite common in patients with schizophrenia like any other illness, and it should be addressed3 because noncompliance and aggression risk profile symptoms are positively correlated to hospitalization4.
Non-compliance is also common in Pakistan like any other society. The commonest reasons for non-compliance are unawareness of the benefits of treatment, non affordability of drugs, physical side effects, no awareness given by the doctor and unfriendly attitude of doctors5.
Educational therapy both for patient and family led to significant psychopathological improvement at post-treatment and at follow-up.6 The recent trend of family intervention produced many models. One long-term family based intervention reduced the risk of psychotic relapse to about the half within the first two years. These methods also shorten hospital stays, improve compliance with medication, patients' social functioning and relatives' well-being, and they seem to be cost-effective.7 Definitive relationship exists between compliance and the economic costs of schizophrenia as lower rates of compliance lead to higher costs of treating schizophrenia8.
Family education on schizophrenia in China was effective in improving knowledge and promoting improvement in patients' symptoms9. A largest randomized controlled trial from china10 have led to increase enthusiasm about psychosocial treatment for schizophrenia but question remains about comparative benefit of treatment methods and additional methods of multiple treatment11.
Mostly research done on role of psychosocial-education in schizophrenia is from developed countries but no work has been done yet in developing country like Pakistan even Subcontinent having a different cultural background. Realizing the need for maintaining the compliance and continuity of treatment, I have designed a study program called Supervised Treatment of Outpatient Schizophrenia. This study aims to evaluate the effectiveness of Supervised Treatment versus the usual care provided in the outpatient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizoaffective disorder based on the ICD-10 criteria for schizophrenia.
- Patients requiring treatment in outpatients
- Residence in Peshawar district
- Patient living with relative(care giver) for at least six months.
Key exclusion criteria (3 listed)
- Evidence of organic mental disorder
- Evidence of mental retardation
- Severe drug dependence requiring inpatient treatment and/or detoxification
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 |
|---|---|---|
| Supervised Treatment of Schizophrenia by a family member | Behavioural | – |
Primary outcome
To compare the compliance in patients suffering from schizophrenia with Supervised Treatment in Outpatients for Schizophrenia with Treatment As Usual (TAU, control group)
1 secondary outcome
To compare the effectiveness of Supervised Treatment in Outpatients of Schizophrenia with Treatment As Usual (TAU, control group) in preventing relapse and rehospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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.
Saeed Farooq, MCPS,FCPS principal investigator
• Associate Professor, and Head Department of Psychiatry, Postgraduate Medical Institute, (P.G.M.I) Hayat Abad Medical Complex, Peshawar, Pakistan and consultant Psychiatrist Lady Reading Hospital, Peshawar. Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Supervised Treatment of Schizophrenia by a family member in people with Schizophrenia and Schizoaffective Disorders, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
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 3 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 27 Feb 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 Pakistan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare the compliance in patients suffering from schizophrenia with Supervised Treatment in Outpatients for Schizophrenia with Treatment As Usual (TAU, control group). 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 27 Feb 2008.