Supervised Treatment of Schizophrenia, a Randomized Controlled Trial.
Supervised Treatment in Outpatients for Schizophrenia (STOPS)Versus Treatment as Usual in Outpatients, a Randomized Controlled Trial.
1 other identifier
interventional
110
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 schizophrenia
Started Nov 2006
Typical duration for phase_1 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2006
CompletedFirst Posted
Study publicly available on registry
October 25, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFebruary 27, 2008
February 1, 2008
1.8 years
October 24, 2006
February 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Evidence of organic mental disorder
- Evidence of mental retardation
- Severe drug dependence requiring inpatient treatment and/or detoxification
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry
Peshawar, Khyber Pakhtunkhwa, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
October 24, 2006
First Posted
October 25, 2006
Study Start
November 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
February 27, 2008
Record last verified: 2008-02