IRCT2017013032236N2
Completed
Phase 2
Study of the efficacy and safety of memantine as an adjuvant to antipsychotics on improving positive and negative symptoms in patients with residual schizophrenia
Vice chancellor for research, Mazandaran University of Medical Sciences0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vice chancellor for research, Mazandaran University of Medical Sciences
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\- Male or female are recruited from in\-patient units in yahyaneghad hospital located in Babol 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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