Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Modafinil tablets: 100 mg mornings Orally once daily for 1 week
then 200 mg for 8 weeks
dose can be reduced to 100 once daily if indicated
Control Intervention1: Placebo tablets: identical placebo tablets orally once daily for 9 weeks
Sponsors
Fluid Research Fund Christian Medical College Vellore
Prof. BV Moses Centre for Clinical trials and Evidence Based Medicine, Christian Medical College, Vellore 632002
Eligibility
Inclusion criteria
Inclusion criteria: • People of both genders with a diagnosis (DSM IV) of schizophrenia or schizoaffective disorder on stable doses of clozapine for at least 4 weeks • Age 18 years or above • In stable remission from psychotic symptoms, as defined by a score of 3 or less on positive psychotic symptoms items of the Positive Symptoms subscale of the Positive and Negative Symptoms Scale (PANNS) for the previous 4 weeks and without manic or hypomanic symptoms (for participants with schizoaffective disorder). • Has subjectively experienced troublesome drowsiness and hyper-salivation with/without weight gain for which the person is willing to try additional medication • Inpatients or outpatients at the department of psychiatry in whom follow up visits and telephone contact are possible • Provides informed consent to participate in the study with additional assent from a responsible relative.
Exclusion criteria
Exclusion criteria: • Active psychotic symptoms or treating clinician considers adding modafinil to pose an unnecessary risk. • Unstable general medical conditions, such as uncontrolled hypertension, unstable angina, and uncontrolled seizure disorder, etc. • Prior trial of modafinil in the previous six weeks or hyper-sensitivity to modafinil • Pregnant or lactating women
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Adverse events checklistTimepoint: 2 weeks, 5 weeks, 9 weeks;Change in mean systolic and diastolic blood pressureTimepoint: Baseline, 9 weeks;Change in weight from baselineTimepoint: Baseline, 9 weeks;Clinical Global Impressions- improvement (physician-rated, participant and carer reported for alertness, hyper-salivation, overall improvement)Timepoint: 2 weeks, 5 weeks, 9 weeks;Disability (IDEAS scores)Timepoint: 2 weeks, 5 weeks, 9 weeks;Mean systolic and diastolic blood pressureTimepoint: 9 weeks;Mean weightTimepoint: 9 weeks;PANSS scoresTimepoint: 2 weeks, 5 weeks, 9 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion without daytime sleepinessTimepoint: 2 weeks, 5 weeks, 9 weeks;Proportion without hyper-salivationTimepoint: 2 weeks, 5 weeks, 9 weeks;Scores on Epworth Sleepiness ScaleTimepoint: 2 weeks, 5 weeks, 9 weeks;Scores on the Nocturnal Hyper-salivation rating scaleTimepoint: 2 weeks, 5 weeks, 9 weeks. | — |
Countries
India
Contacts
Public ContactSebind Kumar
Christian Medical College, Vellore
Outcome results
None listed