Neuroleptics in adults with Aggressive CHallenging Behaviour and Intellectual Disability

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11736448

Enrollment

Registered

2003-04-25

Start date

2002-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental and behavioural disorders: Schizophrenia and other psychoses Mental and Behavioural Disorders Schizophrenia

Interventions

A three-arm double blind parallel design trial of placebo, haloperidol and risperidone. Block randomisation utilised with even distribution of each drug in every block, thus no gross disparity. Assess

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have not taken any depot anti-psychotics in the past three months or oral anti-psychotics in the past week but may have received anti-psychotics in the past.

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Multi-axial Classification - multi-axial classification DSM-IV format with ICD10 codes. 2. Mini PAS-ADD - for psychiatric symptoms. 3. Modified Overt Aggression Scale (MOAS) - for aggressive challenging behaviour (ACB). (primary outcome measure) 4. Aberrant Behaviour Checklist (ABC) - Community - for challenging behaviour (ACB). (secondary outcome measure) 5. Client Service Receipt Inventory (CSRI) - Short version for service costs. (secondary outcome measure) 6. Clinical Global Impressions Scale (CGI) - for illness and global improvement. 7. Uplift/Burden Scale - for burden of care of carers. 8. Quality of Life Questionnaire (QOL-Q) - client quality of life. 9. Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale - includes extra-pyramidal side effects.	—

Measure

Time frame

1. Multi-axial Classification - multi-axial classification DSM-IV format with ICD10 codes. 2. Mini PAS-ADD - for psychiatric symptoms. 3. Modified Overt Aggression Scale (MOAS) - for aggressive challenging behaviour (ACB). (primary outcome measure) 4. Aberrant Behaviour Checklist (ABC) - Community - for challenging behaviour (ACB). (secondary outcome measure) 5. Client Service Receipt Inventory (CSRI) - Short version for service costs. (secondary outcome measure) 6. Clinical Global Impressions Scale (CGI) - for illness and global improvement. 7. Uplift/Burden Scale - for burden of care of carers. 8. Quality of Life Questionnaire (QOL-Q) - client quality of life. 9. Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale - includes extra-pyramidal side effects.

—

Secondary

Measure	Time frame
Not provided at time of registration.	—

Countries

Australia, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026