Supervised Treatment of Schizophrenia, a Randomized Controlled Trial.
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|ClinicalTrials.gov Identifier: NCT00392249|
Recruitment Status : Unknown
Verified February 2008 by Lady Reading Hospital, Pakistan.
Recruitment status was: Active, not recruiting
First Posted : October 25, 2006
Last Update Posted : February 27, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorders||Behavioral: Supervised Treatment of Schizophrenia by a family member||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Supervised Treatment in Outpatients for Schizophrenia (STOPS)Versus Treatment as Usual in Outpatients, a Randomized Controlled Trial.|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||September 2008|
|Estimated Study Completion Date :||September 2008|
- To compare the compliance in patients suffering from schizophrenia with Supervised Treatment in Outpatients for Schizophrenia with Treatment As Usual (TAU, control group)
- To compare the effectiveness of Supervised Treatment in Outpatients of Schizophrenia with Treatment As Usual (TAU, control group) in preventing relapse and rehospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392249
|Department of Psychiatry|
|Peshawar, Nwfp, Pakistan|
|Principal Investigator:||Saeed Farooq, MCPS,FCPS||• 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|