Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/12/2013
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

Dr Craig Ritchie

ORCID ID

Contact details

Metabolic and Clinical Trials Unit
Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 020 7794 0500 x3951

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0530115316

Study information

Scientific title

Acronym

Study hypothesis

The aim of the study is to determine the effect that the addition of pindolol has on weight gain associated with Olanzapine. We hypothesise that due to its central effects on serotonergic pathways, pindolol will increase feelings of satiety and consequently reduce weight gain commonly observed in the treatment of psychosis with Olanzapine.

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

Obesity

Intervention

Randomised controlled trial:
A. Olanzapine treatment in combination with pinadolol
B. Olazapine treatment alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Olanzapine is commonly used in the treatment of schizophrenia. Whilst generally well tolerated, weight gain is known to effect compliance and acceptability to many patients. In patients who continue to take Olanzapine despite gaining weight there are general health and psychological ramifications. If weight gain could be minimised then this burden may be reduced, leading to a lessening of pressure upon NHS resources.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2002

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

36 Participants, who will be recruited through the clinicians working with Camden and Islington Mental Health and Social Care Trust.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

36

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2002

Recruitment end date

01/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Metabolic and Clinical Trials Unit
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

North Central London Community Research Consortium

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