IRCT2017013032236N3CompletedPhase 4
Study of the efficacy and safety of aripiprazole as an adjuvant to antipsychotics in patients with residual schizophrenia: A 12-week, randomized, double-blind, placebo-controlled clinical trial
Vice chancellor for research, Mazandaran University of Medical Sciences0 sites50 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 65 years (—)
- Sex
- All
Inclusion Criteria
- •1- Male or female inpatients in two long-stay Psychiatric Care and Rehabilitation Centers which are Supervised by Iranian Rehabilitation Institute located in Sari in the north of Iran
- •2-18–65 years at the time of screening
- •3-With a diagnosis of schizophrenia(paranoid, disorganized, catatonic, or undifferentiated type)or schizoaffective disorder, based on the Structured Clinical Interview for DSM-V and they are suffering from the disease for more than 2 years with residual symptomatology despite antipsychotic treatment
- •4- All patients are on antipsychotics for at least 1 year and a stable dose for at least 2 month are included in the trial and the antipsychotics dose remain unchanged during the trial.
- •5-Mood stabilizers (lithium and divalproex) and antidepressants (only the selective serotonine reuptake inhibitors (SSRIs) venlafaxine, and mirtazapine) were permitted as part of antipsychotic pharmacotherapy. Dose of these drugs must be stable for at least 2 month remain unchanged during the trial.
- •Exclusions criteria:
- •1-Acute relapse (As acute relapse was defined an impending decompensation based on a PANSS score of =4 (moderately) on the subscore items of hostility and uncooperativeness and/or a =20% increase in the PANSS total score.
- •2-Psychiatric comorbidity(primary or secondary diagnosis of bipolar I disorder, either manic or mixed episode, as defined by DSM-V)
- •3-History of substance dependence (including alcohol, but excluding nicotine) as defined by DSM-V and relapse within the past 6 months, or substance abuse within the 3 months preceding the trial or positive urine test for illicit drugs
- •4-Electroconvulsive therapy during the 6 past months
- •5-Suicidality(active suicide or homicide intent, or a suicide or homicide attempt in the preceding 6 months)
- •6-Mental retardation
- •7-Pregnant or at risk of pregnancy
- •8-Cognitive disorders such as dementia, delirium, or amnesia, traumatic brain injury
- •9-Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
- •10-Hypersensitivity to aripiprazole
- •11-Previous treatment with aripiprazole in the past year
- •12-History of neuroleptic malignant syndrome
- •13-Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
Exclusion Criteria
- Not provided
Investigators
Similar Trials
Completed
Not Applicable
A research of efficacy and safety of aripiprazole treatment for the behavioral symptoms in subjects with pervasive developmental disordes.Pervasive Developmental DisordersJPRN-UMIN000006558Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui50
Completed
Phase 2
Effect of aripiprazole in treatment of sexual dysfunction due to antidepressantsCondition 1: Sexual desire. Condition 2: Sexual dysfunction. Condition 3: Orgasm. Condition 4: Ejaculation.Lack or loss of sexual desireSexual dysfunction, not caused by organic disorder or diseaseOrgasmic dysfunctionPremature ejaculationIRCT2017020432236N5Mazandaran University of Medical Sciences60
Not yet recruiting
Phase 4
Comparing the effects of two medications for antipsychotic related weight gain: can adding aripiprazole or naltrexone help?CTRI/2024/02/062617Madhurima Dhar
Not yet recruiting
Not Applicable
To study therapeutic efficacy of aripiprazole augmentation in treatment resistant obsessive compulsive disorderCTRI/2021/04/032524GMC medical college
Completed
Phase 3
Effect of Aripiprazole and Risperidone in Improving Obsessive-compulsive symptoms in Bipolar patientsCondition 1: Obsessive-compulsive disorder. Condition 2: Bipolar disorder.Obsessive-compulsive disorderBipolar disorderIRCT20170716035117N1Kashan University of Medical Sciences60