- Ages Eligible for Study
- 18 years and up
- Genders Eligible for Study
Schizophrenia, Psychosis, Neuroleptics, and Schizoaffective Disorder
- National Institute of Mental Health (NIMH)
- Age 18 or older
- Male or female
- Diagnosis of Schizophrenia, Schizoaffective Disorder or Psychosis NOS. Subjects with
other neuropsychiatric disorders may also be admitted and participate in the protocol
if there is sufficient evidence to believe they have an underlying, undiagnosed
schizophrenia, schizoaffective disorder or psychosis NOS.
- Currently treated with depot medications. Because of the long half-life of depot
medications such as paliperidone palmitate (Invega Sustenna), applicants to our
program will be excluded if they are currently receiving depot medications monthly.
However, applicants may decide to switch from depot to oral medications on their own,
in conjunction with their personal physician, before coming to the program. This is
not part of research and we do not participate in this decision. A sufficient washout
period based on the particular long-acting injectable medication s elimination
half-life will be required in order for prospective participants to be eligible. Most
such medications require a 6-month washout period, but some with shorter elimination
half-lives, such as risperidone powder (Risperdal Consta), only require 3 months.
Subjects may complete the last 3 months of washout in the inpatient unit while being
evaluated under the standard protocol.
- Major medical illness. Research subjects identified as having major medical problems
other than their primary neuropsychiatric disorder will be excluded from admission.
- Applicants judged to be unsuitable for medication free studies will also be excluded.
Possible reasons for exclusion include prior history of dangerousness to self or
others, particularly when off medication.
- Applicants who are pregnant are excluded from this study. Volunteers who are found to
be pregnant after testing will be terminated from study and referred to an OB-GYN for
follow up care.
- Infection with syphilis, hepatitis, or HIV.
- History of of any (excepting nicotine-related) DSM5-defined moderate to severe
substance use disorder (or DSM-IV-defined substance dependence).
- Cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild
substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5
years total or not in remission for at least 6 months.
- Lack of capacity to provide consent.
The purpose of this study is to understand the biologic basis of schizophrenia and to determine which symptoms are related to the illness itself and which are related to medications used to treat the illness. Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure. Brain imaging technologies such s positron emission tomography (PET), functional magnetic resonance imaging (fMRI), and magnetic resonance imaging (MRI) offer opportunities to study the pathophysiology of psychotic disorders by evaluating brain function. However, the use of anti-psychotic drugs may interfere with the results of such studies. In this study, psychotropic medication will be discontinued in patients for a short period of time to distinguish the effects of the illness on the brain without the interference of the medication's effects on the brain. Given that there is a risk that the patient's symptoms will increase, they are asked to stay on an inpatient unit where the NIMH clinical staff is available to help them 24 hours a day. This study will be conducted in three phases. In Phase 1, participants will be admitted to the Clinical Center while continuing to take their medication and will undergo diagnostic interviews, physical and laboratory assessments, physiological monitoring, and neuropsychological testing. Behavioral ratings will also be performed and blood and urine samples will be collected. During Phase 2, participants will continue taking medications in a blinded fashion for 8 to 12 weeks. The active medications will be replaced with a placebo (an inactive pill) part of that time. PET, fMRI, and MRI scans will be used to monitor how the continuation or lack of medication affects the brain. Psychological tests will also be given to measure changes in cognition. In Phase 3, participants will have the opportunity for clinical stabilization.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001247