Schizoaffective Disorder Clinical Trial
Official title:
Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
The purpose of the study was to evaluate the effects of integrated treatment for patients
with a first episode of psychotic illness. We conducted a randomised clinical trial in
Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547
patients with first episode of schizophrenia spectrum disorder, who has not received
antipsychotic medication for more than 12 weeks.
Patients were randomised to integrated treatment or standard treatment. The integrated
treatment lasted for two years and consisted of assertive community treatment with
programmes for family involvement and social skills training. Standard treatment offered
contact with a community mental health centre.
We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack
of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one
and two years' follow-up.
We found that integrated treatment improved clinical outcome and adherence to treatment. The
improvement in clinical outcome was consistent at one year and two year follow-ups. We will
study further outcome measures such as social network, quality of life, depression and
suicidal behaviour.
Objectives: To evaluate the effects of integrated treatment for patients with a first
episode of psychotic illness.
Design: Randomised clinical trial. Setting: Copenhagen Hospital Corporation and Psychiatric
Hospital Aarhus, Denmark Participants: 547 patients with first episode of schizophrenia
spectrum disorder.
Interventions: Integrated treatment and standard treatment. The integrated treatment lasted
for two years and consisted of assertive community treatment with programmes for family
involvement and social skills training. Standard treatment offered contact with a community
mental health centre.
Main outcome measures: Psychotic and negative symptoms (each scored from 0 to a maximum of
5) at one and two years' follow-up.
Results: At one year's follow-up, psychotic symptoms changed favourably to a mean of 1.09
(standard deviation 1.27) with an estimated mean difference between groups of -0.31 (95%
confidence interval -0.55 to -0.07, P=0.02) in favour of integrated treatment. Negative
symptoms changed favourably with a estimated difference between groups of -0.36 (-0.54 to
-0.17, P<0.001) in favour of integrated treatment. At two years' follow-up the estimated
mean difference between groups in psychotic symptoms was -0.32 (-0.58 to -0.06, P=0.02) and
in negative symptoms was -0.45 (-0.67 to -0.22, P<0.001), both in favour of integrated
treatment. Patients who received integrated treatment had significantly less comorbid
substance misuse, better adherence to treatment, and more satisfaction with treatment.
Conclusion: Integrated treatment improved clinical outcome and adherence to treatment. The
improvement in clinical outcome was consistent at one year and two year follow-ups.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
| Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
| Completed |
NCT01878513 -
Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis
|
N/A | |
| Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
| Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
| Not yet recruiting |
NCT04551027 -
Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness
|
N/A | |
| Completed |
NCT02901587 -
Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
|
Phase 1 | |
| Terminated |
NCT02796144 -
MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
|
Phase 4 | |
| Completed |
NCT02160249 -
RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)
|
N/A | |
| Recruiting |
NCT02986490 -
Magnesium Variations and Cardiometabolic Risk in Patients With Antipsychotic Drugs
|
N/A | |
| Completed |
NCT02417142 -
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
|
Phase 4 | |
| Terminated |
NCT02234752 -
Galantamine and Memantine Combination for Cognitive Impairments in Schizophrenia
|
Phase 2 | |
| Completed |
NCT02091388 -
Bioavailability of LY03004 and Risperdal® Consta®
|
Phase 1 | |
| Completed |
NCT01975584 -
Neuroendocrine and Immune Response to Stress in Schizophrenia
|
N/A | |
| Completed |
NCT01992393 -
Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)
|
N/A | |
| Completed |
NCT01945333 -
Personalized and Scalable Cognitive Remediation Approaches
|
N/A | |
| Terminated |
NCT02149823 -
Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations
|
Phase 1 | |
| Completed |
NCT01683539 -
Understanding How Cognitive Remediation Works
|
N/A | |
| Completed |
NCT01658150 -
Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder
|
N/A | |
| Completed |
NCT01292577 -
Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia
|
Phase 1/Phase 2 |