About this trial
The study wishes to examine whether "extended" antipsychotic treatment, in this case, antipsychotic treatment every other day, is as effective as daily treatment. It is also evaluating whether there may be differences in terms of side effects.
Participants will be randomly assigned to either the treatment as usual group (i.e., taking antipsychotic daily) or the extended dosing group (i.e., taking antipsychotic one day on, one day off). That means, like flipping a coin, there is a 50/50 chance that participants will continue on daily dosing of your antipsychotic or have it switched to every other day dosing.
This study will last for 1 year. Participants will be evaluated at the beginning and every two weeks during the first 6 months, with visits once every 4 weeks for the final 6 months. In total, participants will make 22 visits over 52 weeks to the investigator's office.
The investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Risperidone
Drug0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Tablets
Olanzapine
Drug2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg Tablets
paliperidone
Drug3 mg, 6 mg, 9 mg Tablets
Treatment groups
Trial outcomes
Primary outcomes
Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded"
Change in the Brief Psychiatric Rating Scale - total scores from baseline to 52 weeks. The score values for each item on the BPRS range from 1 to 7. The higher the score for each item the worse the outcome. The values for each item on the BPRS are scored as follows: 1- Not Present, 2 - Very Mild, 3- Mild, 4- Moderate, 5 - Moderately Severe, 6- Severe, 7- Very Severe.
Secondary outcomes
Exploratory Outcomes - Symptoms 1 using "The Clinical Global Impression - Schizophrenia Scale"
Change in Clinical Global Impression - Schizophrenia (CGI-SCH) severity of illness scores from baseline to 52 weeks. The severity of illness score values for each item on the CGI- SCH range from 1 to 7. The higher the score for each item the worse the outcome. The severity of illness values are scored as follows: 1- Normal, not ill, 2 -Minimally ill, 3- Mildly ill, 4- Moderately ill, 5 - Markedly ill, 6- Severely ill, 7- Among the most severely ill.
Exploratory Outcomes - Symptoms/Side Effects using "The Clinical Global Impression - Schizophrenia Scale"
Change in Clinical Global Impression - Schizophrenia Scale (CGI-SCH) degree of change scores from baseline to 52. The values range from 1-7. The higher the score for each item the worse the outcome. The score value of each item are as follows: 1 - Very much improved, 2 - Much Improved, 3 - Minimally improved, 4 - No Change, 5 - Minimally Worse, 6- Much Worse, 7 - Very Much Worse
Exploratory Outcomes - Symptoms 3 using the "Calgary Depression Scale for Schizophrenia"
Change in Calgary Depression Scale (CDS) scores from baseline to 52 weeks. Scores range from 0-3 as follows: 0- Absent, 1- Mild, 2- Moderate, 3 - Severe. The higher the score for each item, the worse the outcome.
Exploratory Outcomes - Symptoms 4 using the "Yale-Brown Obsessive-Compulsive Scale"
Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) scores from baseline to 52 weeks. Scores range from 0-4 with higher scores indicating worsening of outcome.
Sponsors and contacts
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