Status:
COMPLETED
Comparison of Combination Olanzapine+Lithium or Chlorpromazine+Lithium in Treatment of First Manic Episode With Psychotic Features
Lead Sponsor:
Melbourne Health
Conditions:
Bipolar Disorder
Schizoaffective Disorder
Eligibility:
All Genders
15-29 years
Phase:
PHASE4
Brief Summary
Aim: In a population of first episode manic patients with psychotic features, we want to compare the side effect profile, the degree of adherence and the subjective well being, as well as the efficacy...
Detailed Description
This prospective single-centre open trial will compare two groups receiving two different neuroleptics combined with lithium during the first 8 weeks of treatment of a first manic episode. All the pat...
Eligibility Criteria
Inclusion
- Male and female patients aged 15 to 29.
- Experiencing a first episode psychosis.
- Meet DSM-IV criteria for bipolar either manic or mixed episode, or schizoaffective disorder manic episode.
- Minimum score of 20 on the YMRS
- Written informed consent to participation.
Exclusion
- Patients at immediate risk of committing harm to self or others
- Use of neuroleptics or mood-stabilisers in the two months preceding admission to EPPIC
- Organic mental disease, including mental retardation
- History of clinically significant illness (liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances).
- Clinically relevant biochemical or hematological abnormalities.
- Pregnant or lactating woman
- History of epilepsy
- History of severe drug allergy or hypersensitivity
- Non fluency in English.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00202293
Start Date
October 1 2001
End Date
November 1 2015
Last Update
August 31 2018
Active Locations (1)
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1
ORYGEN Youth Health
Parkville, Victoria, Australia, 3052