Condition category
Mental and Behavioural Disorders
Date applied
18/06/2014
Date assigned
11/09/2014
Last edited
11/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The Nottingham study of neurotic disorder (NSND) was set up in 1983 to look at both the short and long term outcome of common anxiety and depressive disorders. In particular, it examined whether separately classifying individual neurotic disorders (for example into depression, bipolar affective disorder, social anxiety disorder) was actually helpful for either science or in treating sufferers of these conditions. Many patients were found to be have a mixed anxiety/depression disorder and could be considered to suffer from a general neurotic syndrome. The study investigated whether diagnosing a patient as suffering from a general neurotic disorder rather than making a conventional clinical diagnosis made any difference to predicting how the patient responded to treatment, or whether some modes of treatment (different treatments) were more successful than others. Data for the study has been collected on 9 further occasions since 1983, the last time being 12 years after the start of the trial. We are now repeating the assessments after 30 years as neurotic disorders can have some very long-term effects.

Who can participate?
Adults on no active treatment at the start of the study and diagnosed with generalized anxiety disorder, neurotic depression or panic disorder.

What does the study involve?
Participants are asked to attend a single follow up interview lasting about 85 minutes. The questions cover psychiatric diagnosis and symptoms, personality and social functioning, and service contacts. Written permission to access the patients' general practice medical notes is also requested at the beginning of the interview.

What are the possible benefits and risks of participating?
The patients have been followed up many times previously and have been seen by the same investigator, Dr Helen Tyrer, on the last occasion. Many look forward to the updated assessment and all of those approached at 12 years who gave consent to be seen at 30 years have been noted. At 12 years we had very positive views about the study and its progress. 4 patients who said they did not want to be followed up will not be seen at 30 years. We do not think there are any particular risks of the study – all data to be obtained have been asked about before. We will also be carrying out an interview to find out what major events have occurred over the past 30 years. This will include finding out how much each event has affected their mental health, and how it came about. This is part of a formal investigation into nidotherapy, the changing of the environment to better fit a person and their surroundings.

Where is the study run from?
Imperial College London (UK)

When is the study starting and how long is it expected to run for?
January 2014 to June 2017

Who is funding the study?
1. Department of Health – Offender Health (UK)
2. Nicola Pigott Memorial Fund (UK)

Who is the main contact?
Professor Peter Tyrer
p.tyrer@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Tyrer

ORCID ID

Contact details

Department of Psychological Medicine
The Reynolds Building
St. Dunstans Road
London
W6 8RP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16681

Study information

Scientific title

30-year follow-up of personality and clinical status of patients with anxiety and depression in the Nottingham Study of Neurotic Disorder: an observational cohort study following a randomised trial

Acronym

Nott30

Study hypothesis

This is a long-term follow-up of patients recruited to a randomised controlled trial of cognitive behaviour therapy, drug therapy and self-help in 1988, and although this has now become a cohort study in the first two years of the trial the mode of therapy was kept the same as that randomised.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16681

Original trial can be found at: http://www.ncbi.nlm.nih.gov/pubmed/2899234

Ethics approval

12/EM/0331; First MREC approval date 21/11/2012

Study design

Randomised; Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health; Subtopic: Anxiety, Depression; Disease: Depression, Anxiety

Intervention

In the original trial the patients were randomised to one of three drug treatments (diazepam, dothiepin and placebo), cognitive behaviour therapy or self-help, and most of the patients (70%) maintained this allocation for the first 2 years of this study.

1. Cognitive behaviour therapy: 3-6 sessions of treatment given by a trained nurse under supervision from an established therapist
2. Diazepam: matching tablets of diazepam (5-30 mg daily) with ascending dosage to preferred maximum over 6 weeks then reduction to zero by 10 weeks
3. Dothiepin, matching tablets of dothiepin (25-150 mg daily) with ascending dosage to preferred maximum over 6 weeks then reduction to zero by 10 weeks
4. Placebo: matching placebo medication
5. Self-help: relaxation tape and self-help instructions

Follow Up Length: 360 month(s); Study Entry : Registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Comprehensive Psychopathological Rating Scale; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years

Secondary outcome measures

1. DSM diagnosis; Timepoint(s): baseline, 10, 16, 32, 52, and 104 weeks, and follow-up at 12 and 30 years
2. Hospital admission; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
3. Hospital Anxiety and Depression Scale - Anxiety section; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
4. Hospital Anxiety and Depression Scale - Depression Section; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
5. Montgomery-Asberg Depression Rating Scale; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years
6. Neurotic Disorder Outcome Scale (NDOS); Timepoint(s): baseline, 5, 12 and 30 years
personality status; Timepoint(s): baseline, 2 years, 12 and 30 years
7. Social Functioning Questionnaire; Timepoint(s): 12 and 30 years
8. Suicidal behaviour; Timepoint(s): baseline, 2, 4, 6, 10, 16, 32, 52, and 104 weeks, and follow-up at 5, 12 and 30 years

Overall trial start date

01/01/2014

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. On no active treatment at baseline
2. Satisfies diagnostic criteria for GAD, dysthymia or panic disorder
3. Target Gender: Male & Female

The participants to the original trial (Tyrer et al, 1988) were:
1. Aged between 18 and 65
2. Seen in general practice psychiatric clinics
3. Following the diagnostic criteria of the then new American diagnostic classification (DSM-III)) had a diagnosis of dysthymia (formerly neurotic depression), generalised anxiety disorder or panic disorder
4. Were not on any form of therapy for mental disorder at the time of randomisation

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Planned Sample Size: 130; UK Sample Size: 130; Description: Patients with a DSM-III diagnosis of generalised anxiety disorder, dysthymia and panic disorder seen in general practice psychiatric clinics

Participant exclusion criteria

Lack of informed consent

Recruitment start date

01/01/2014

Recruitment end date

30/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
London
W6 8RP
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Government

Funder name

Department of Health – Offender Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nicola Pigott Memorial Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes