Condition category
Mental and Behavioural Disorders
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
23/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor SW Lewis

ORCID ID

Contact details

School of Psychiatry and Behavioural Science
University of Manchester
Withington Hospital
West Didsbury
Manchester
M20 8LR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9519373

Study information

Scientific title

Acronym

SOCRATES

Study hypothesis

To evaluate the effectiveness of cognitive behaviour therapy in parallel with drug treatments as usual in early acute schizophrenia. The hypothesis is that CBT is an acceptable adjunct to drug treatment which will accelerate resolution of target psychotic symptoms and reduce relapse.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Neurosciences, psychiatry

Intervention

Cognitive behaviour therapy/drug treatments

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Change on core symptom scores on hallucination and delusion rating scales
2. Change in total symptoms scores on PANSS
3. Time to criterion of 50% recovery operationally defined -
4. Number of days in hospital before 1st discharge and during follow-up
5. Time to relapse
6. Follow-up symptom and outcome scores at 3.9 and 18 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1996

Overall trial end date

31/03/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive sample of in- or day-patients admitted with 1st and 2nd episode schizophrenia aged 18-65. Further inclusion criteria:
1. Able to give informed consent
2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition (DSMIV) diagnostic criteria for schizophrenia, schizophreniform or schizoaffective disorder with at least a 1 month history of positive symptoms
3. No significant history of organic brain disease or substance misuses for major aetiological factor for psychosis
4. Positive and negative syndrome scale (PANSS) for schizophrenia score of at least 4 on item hallucinatory behaviour and/or item delusions
5. Score of less than 5 on PANSS item conceptual disorganisation

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

236

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/1996

Recruitment end date

31/03/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychiatry and Behavioural Science
Manchester
M20 8LR
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Lewis, S., Tarrier, N., Haddock, G., et al (2002) Randomised, controlled trial of cognitive-behavioural therapy in early schizophrenia: acute-phase outcomes. British Journal of Psychiatry, 181 (suppl. 43), s91-s97

Publication citations

Additional files

Editorial Notes