Clinical trial NCT02630888: Efficacy of Memantine add-on in the Treatment of Bipolar Disorder (Type I) Nonresponders or Partial Responders Patients
Official title: Efficacy of the Combination of Memantine in the Treatment of Bipolar Disorder (Type I) Nonresponders or Partial Responders Young Patients to Previous Combination Therapy of Quetiapine Plus Lithium or Quetiapine Plus Aripiprazole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Memantine
Lithium
Aripiprazole
Quetiapine
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Psychotropic Drugs
Cognitive effect of drugs
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this study is evaluate the efficacy of memantine association on the treatment with a previous combination of two drugs, including quetiapine with lithium or quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders or partial responders to that combination of drugs and evaluate the impact of this association at the cognitive functioning of the patients.

Detailed description: Current evidence suggests that deregulation of brain glutamatergic neurotransmission is involved in the pathophysiology of bipolar disorder and that drugs that intervene in this transmission may be therapeutic weapons in addressing the symptoms and cognitive deficits of this pathology. Among these drugs, particularly memantine is a strong candidate in view of their efficacy in antagonizing N-methyl-D-aspartate (NMDA) receptors, and their good safety and tolerability profile. The principal aim of this study is to evaluate the efficacy of memantine association with treatment with a combination of two drugs, including quetiapine with lithium and quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders or partial responders and evaluate the impact of this association cognitive functioning of patients. An experimental study, randomized, double-blind, bipolar patients with type 1, of both sexes, aged 18 to 40, ambulatory or hospitalized, at any stage of the disease, seeking treatment in the Mood Disorders Program (GRUDA) of Institute os Psychiatry (IPq) of Sao Paulo University (FMUSP). Patients will come from ARIQUELI Project (Missio, G. et al, 2013 submitted Trial registration - ClinicalTrials.gov Identifier:. NCT01710163).

The study will be conducted in two stages: I - initial administration of memantine or placebo for 8 weeks; II - Maintenance administration for more 4 months.

Eligibility criteria: * INCLUSION CRITERIA:

  1) Partial responders or non-responders (HAM-D score \> 7 points and/or YMRS \> 9 points) in the ARIQUELI Study (after quetiapine + lithium or quetiapine + aripiprazole combination).
* EXCLUSION CRITERIA:

  1. Patients with Schizophrenia, Schizoaffective Disorder or Mental Retardation (Intellectual Quotient Total less than 90);
  2. Patients with severe, unstable diseases, including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological;
  3. Hypo or hyperthyroidism uncorrected;
  4. Angle-closure glaucoma;
  5. Changes in blood coagulation or use of regular anticoagulants;
  6. Patients with serious risk of suicide (according to clinical criteria and / or score\> = 4 in the HAM-D item suicide) may participate in the study only in inpatients;

Primary outcomes:
measure: Memantine efficacy in stabilizing mood
timeFrame: 8 weeks
Secondary outcomes:
measure: Memantine impact in the cognitive functioning
timeFrame: 24 weeks (6 months)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Psychiatry, University of Sao Paulo
Study officials:
affiliation: Sao Paulo University
name: Ricardo A. Moreno, MD, PhD
role: STUDY_DIRECTOR
References: