The proposed study goals are to test whether it is possible 1) to maximize the benefits and reduce the risks of maintenance drug treatment for schizophrenia by using reduced dose strategies; 2) to employ a family management intervention to further reduce the risk of relapse, and improve social and intrafamilial functioning. The proposed study is part of a collaborative project sponsored by the NIMH. Patients will be stabilized on fluphenazine decanoate (FD) and then randomly assigned to one of the following treatment to continue for two years: continuous low dose (FD .2.5 to 10mg every two weeks); continuous standard dose (FD 12.5 to 50mg every two 'weeks); discrete targeted early intervention (placebo FD 1/2 to 2cc q two weeks). Each patient will also be randomly assigned to either applied or supportive family management. For all patients, episodes of symptom exacerbation will be treated openly with oral fluphenazine or FD, in addition to the """"""""blind"""""""" study medication, without breaking the blind. Once the episode is resolved, patients will continue on study treatment only. Patients who require open medication for more than 120 days will be terminated from the double-blind medication but continued in family management for '.the full two years. Patients assigned to applied family management will receive individual family sessions according to a predetermined schedule for the first year. Families of all patients will attend a psychoeducation workshop and have the opportunity to attend monthly group meetings throughout the two year period. Outcome measures will include relapse rates, measures of psychopathology, social functioning and side effects. Additional data will be collected to compare the cost effectiveness of the six treatments. This will include the cost of study treatments, other health care and public interventions and lo t family work productivity as well as offsetting gains. Patients who fail to stabilize initially within six months on open FD or who relapse and fail to restabilize after 140 days of open medication treatment will be asked to consent to the following: an eight week double-blind randomized trial of lithium or lithium placebo in addition to open treatment with FD and continuation, of the assigned family management.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10MH039992-07
Application #
3560431
Study Section
Special Emphasis Panel (SRCM (20))
Project Start
1984-09-20
Project End
1992-08-31
Budget Start
1990-09-01
Budget End
1991-08-31
Support Year
7
Fiscal Year
1990
Total Cost
Indirect Cost
Name
Long Island Jewish Medical Center
Department
Type
DUNS #
City
New Hyde Park
State
NY
Country
United States
Zip Code
11040
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