Research Study Opportunity: Preventing Psychosis Onset

I. Background
 We know that schizophrenia can be a devastating illness for patients and
for their families.  Recently, preliminary evidence suggests that early
intervention (medication and psychosocial treatment), even before the
beginning of psychosis, can improve the course of the illness when it does
become manifest, and make it less severe.  This pre-psychotic period before
the onset of psychosis is called the "prodromal phase" and has been found to
be associated with the following symptoms:
  Having more difficulty working or studying
  Trouble thinking, concentrating, or focusing
  Feeling very tired or lacking in energy
  Feeling paranoid or worried about the intentions of other people
  Sensing changes in the way things sound or look, or noticing things in the
environment that others don't notice
  Feeling strange or having ideas that others find unusual
  Feeling uncomfortable around friends and wanting to be alone more often
than unusual
  Having troubled feelings that are new or different or surprising, such as
tension, anger, suspiciousness, or fear
  Not having feelings when it normal to do so
  Feeling very confused and unclear about one's identity and future

II. Study Overview
 Currently, the PRIME (Personal Risk Identification, Management, and
Education) Clinic is at the Yale Medical School in New Haven, Connecticut,
and is recruiting individuals for a treatment study to test if early
treatment can prevent the onset of psychosis.  The study lasts for two years
and requires a total of 27 visits to the PRIME Clinic in New Haven, CT for a
year of treatment and a year of follow-up. At first the visits are weekly
and later they are monthly.  Also, in the first year, all persons who agree
to participate and meet prodromal phase criteria will be placed in one of
two groups at random.  The first group will take a new atypical
anti-psychotic medication being used to treat psychosis and is being tested
here to see if it can prevent psychosis.  The other group will take a
placebo (sugar pill) for the same time period.  No one will know who is
receiving the placebo or who is receiving the new atypical anti-psychotic
medication. All participants will also receive a psychosocial intervention
consisting of stress management and problem-solving skills training.
During both years, participants will be interviewed at regular intervals to
assess their status, but during the second year they will not receive
treatment from the clinic.  However, anyone who develops psychosis at any
time during the course of the study will immediately start receiving the new
atypical anti-psychotic medication no matter which group they belong to.
The treatment is provided free of charge, but it does require an ability and
willingness to travel to New Haven to participate.  Travel expenses by car
and/or train can be reimbursed.

III. Famliy Involvement
If someone in your family has a mental illness, you may also have other
children or siblings who have a mental illness.  As you may already know,
children with a sibling with schizophrenia are 10 times more likely to
develop schizophrenia themselves, as opposed to people who do not have an
affected child or sibling.  Therefore, it is possible that you, or someone
in your family besides the family member who is already receiving services
for mental illness, might benefit from an evaluation at our clinic.  This is
especially true if that person is displaying any of the symptoms listed above.

IV. Opportunity to Participate
If you are concerned and would like to learn more about the study and our
clinic, feel free to call 1 (800) ASK-YALE.  All contacts with our clinic
are strictly confidential.


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