A randomized trial comparing adjunctive modafinil with placebo for clozapine related adverse effects in people with schizophrenia or schizoaffective disorder in remission.

Phase 4

Suspended

Conditions: Health Condition 1: null- Schizophrenia
Schizoaffective disorder
Clozapine related adverse effects

Registration Number: CTRI/2007/091/000020

Lead Sponsor: Fluid Research Fund Christian Medical College Vellore

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 60

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

•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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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