Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01520350
Other study ID # ARI_1109
Secondary ID
Status Terminated
Phase Phase 3
First received January 25, 2012
Last updated July 28, 2014
Start date February 2012
Est. completion date June 2013

Study information

Verified date July 2014
Source Douglas Mental Health University Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to other antipsychotic agents, especially because of its partial dopaminergic agonistic activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the 5-HT2a receptor, and an agonist of the 5-HT1a receptor. These pharmacological properties should enable this molecule to provide antidepressant potentiating capabilities based on what has been observed with other compounds sharing similar pharmacological profiles.

Aripiprazole is now well recognized for its capacity to potentiate antidepressants in the treatment of unipolar depression. However, two randomized controlled trials of aripiprazole in the treatment of bipolar depression were negative. This surprising result may stem from the fact that the doses of aripiprazole used in these studies were rather high (17.6 ± 8.3 mg/d in study 1 and 15.5 ± 7.5 mg/d in study 2) and could have contributed to inhibit dopaminergic activity in key brain areas involved in the modulation of rewards, motivation and concentration. Bipolar depression is indeed heavily loaded with general symptoms of psychomotor retardation including poor concentration, low energy level, hypersomnolence, and hyperphagia. All these functions are modulated by dopamine and strategies aimed at improving dopaminergic function are used frequently to resolve residual symptoms of bipolar depression.

It is expected that aripiprazole used at a more adequate lower dose than in previous studies, should be efficacious in the treatment of bipolar type I depression.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age : 18-65

- Male or female

- Bipolar Disorder type I

- Current depressive episode (with MADRS = 20 and item 2 (reported sadness) = 3) for a minimum of 2 weeks but = 52 weeks at screening visit and baseline visit)

- If female and of childbearing potential, is using an adequate method of contraception.

- Is treated with a mood stabilizer (lithium and/or valproate)

- Patient is able to give his consent

Exclusion Criteria:

- Is at high risk of suicide as defined by a score of = 3 to item 10 of MADRS and/or in the clinical opinion of the investigator

- Hypo(mania) episode with YMRS = 8

- Psychotic symptoms as defined by a score of = 4 to item 8 (content) of YMRS and/or in the opinion of the investigator

- Is treated with fluoxetine OR lamotrigine OR carbamazepine OR any antidepressants

- Is treated with risperidone OR olanzapine OR quetiapine OR ziprazidone OR any antipsychotics

- Is pregnant or lactating or absence of contraceptive treatment

- Drug abuse or dependence as per DSM-IV (MINI)

- Unstable medical condition

- Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension

- Deficit in vitamin B12 or folate

- Alcohol or drug abuse

- Rapid cycling (more than 4 mood episodes per year)

- Active or history of difficulty to swallow

- Seizures not currently controlled with medications

- Orthostatic hypotension

- A history of clinically significant cardiovascular disorders and cardiac arrhythmias

- A low white blood cell count

- Known eye disease

- Involuntary, irregular muscle movements, especially in the face

- Known hypersensitivity to aripiprazole and any components of its formulation

- Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because ABILIFY tablets contain lactose

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Low dose Adjunctive Aripiprazole
low-dose 2-5mg/d for 8 weeks
placebo
Placebo

Locations

Country Name City State
Canada Douglas Mental Health University Institute Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Serge Beaulieu Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate The primary outcome measure will be the response rate as defined by a differential reduction of 5 points on the Montgomery Asberg rating Scale (MADRS) between the active treatment group and the placebo group at 8 weeks of treatment. 8 weeks No
See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study