Supervised Treatment of Schizophrenia, a Randomized Controlled Trial.

Schizophrenia Clinical Trial

Official title:

Supervised Treatment in Outpatients for Schizophrenia (STOPS)Versus Treatment as Usual in Outpatients, a Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00392249
• Other study ID #: PGMILRH 01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: October 24, 2006
• Last updated: February 25, 2008
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: February 2008
• Source: Lady Reading Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Department of Health NWFP: Pakistan
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of schizophrenia or schizoaffective disorder based on the ICD-10 criteria for schizophrenia.

2. Patients requiring treatment in outpatients

3. Residence in Peshawar district

4. Patient living with relative(care giver) for at least six months.

Exclusion Criteria:

1. Evidence of organic mental disorder

2. Evidence of mental retardation

3. Severe drug dependence requiring inpatient treatment and/or detoxification

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorders
• Schizophrenia

Intervention

Behavioral:
• Supervised Treatment of Schizophrenia by a family member

Locations

Country	Name	City	State
Pakistan	Department of Psychiatry	Peshawar	Nwfp

Sponsors (2)

Lead Sponsor	Collaborator
Lady Reading Hospital, Pakistan	GTZ Pakistan (German Technical Cooperation)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the compliance in patients suffering from schizophrenia with Supervised Treatment in Outpatients for Schizophrenia with Treatment As Usual (TAU, control group)
Secondary	To compare the effectiveness of Supervised Treatment in Outpatients of Schizophrenia with Treatment As Usual (TAU, control group) in preventing relapse and rehospitalization