Research Studies

Please click on the title of each study to visualize the description...

Ongoing studies

* Treatment of ADHD in Euthymic Adults with Bipolar I/II Disorder

Vyvanse is a psychostimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Several epidemiological and clinical studies have documented a high rate of lifetime ADHD in children with bipolar disorder. Comorbid ADHD is associated with a more complex illness presentation and decreased response to lithium in young populations with bipolar disorder. Features of ADHD often persist into adulthood. Relatively few studies have evaluated the diagnostic and clinical implications of lifetime ADHD comorbidity in adults with bipolar disorder. Existing evidence indicates that Vyvanse not only offers efficacy for ADHD symptoms across age populations, but also offers a favorable metabolic profile. This study aims to evaluate the safety and efficacy of Vyvanse in the treatment of ADHD symptomatology in adult individuals with BD.

* Cognitive Enhancement in Clinically Stable Patients with Bipolar Disorder

Recent evidence suggests multiple different cognitive impairments in manic, depressed and clinically stable phases of bipolar disorder. These include abnormalities in attention/vigilance, executive functioning, episodic memory, and working memory. Several studies have reported minimal differences between euthymic and hypomanic or euthymic and mildly depressed patients with bipolar disorder. The lack of recovery despite high levels of clinical response implicates persistent cognitive deficits as a source of disability. Furthermore, incomplete recovery is associated with reductions in quality of life, but only minimally with symptoms. Quetiapine has been reported to have beneficial cognitive effects in several randomized controlled trials in schizophrenia. Cognitive enhancement in bipolar disorder appears to have the same potential for functional benefit as in schizophrenia. In this study, we propose to study quetiapine augmentation of mood stabilizer monotherapy in clinically stable patients with bipolar disorder.

* Antidepressants in the Maintenance Treatment of Bipolar Disorder

Individuals with bipolar I disorder experience depression 3 times more frequently than mania. The consequences of depression have at least as severe an impact on health and functioning as mania. The mood stabilizing medications and the second-generation antipsychotics (SGAs) have all been demonstrated to prevent mood episodes during the long-term treatment of bipolar I disorder. However, commonly-used maintenance treatments are more effective in preventing mania than depression. Antidepressants are prescribed for up to 70% of patients with bipolar I disorder, and half of patients prescribed antidepressants continue to take them for one year or longer. This study will test whether continuing antidepressant treatment for 12 months reduce the risk of relapse into any mood episode compared to discontinuing the antidepressant and substituting it with placebo after 2 months, in patients with bipolar depression who respond to acute treatment with escitalopram or bupropion XL in combination with a mood stabilizing medication, an SGA, or a mood stabilizer plus an SGA.

Coming soon

* Intranasal Insulin: An Adjunctive Treatment for Treatment-Resistant Depression

Major depressive disorder is the most common illness suffered by psychiatric patients. Although major depressive disorder can be treated directly through a number of clinically proven antidepressant therapies, approximately 50% of patients do not respond to them. Treatment resistant depression is the inability of a patient diagnosed with unipolar depressive disorder to respond to antidepressant therapy and achieve remission. In order to diagnose treatment resistant depression, a patient must fail to respond to adequate antidepressive therapy. The most widely accepted definition of treatment resistant depression is failure to remit with 2 antidepressants adequately dosed at a sufficient duration in the index trial. Studies conducted have shown evidence of elevated moods and enhanced cognitive function in patients with major depressive disorder treated with intranasally administered insulin. Intranasally administered insulin may access the brain through several specific pathways. This study will test the hypothesis that the intranasal administration of insulin is a novel and safe treatment for depression in patients with major depressive disorder who have shown resistance to antidepressants.

* Bipolar Depression

Bipolar I disorder is a common, recurrent, often disabling and potentially life-threatening illness. Patients with this disorder may spend one-third of their lives coping with depressive symptoms. Morbidity from depression is estimated to be at least 3 times as common as manic or hypomanic morbidity and is associated with a substantial risk of suicide. There remains a clinical need to develop additional therapies for bipolar depression. In Canada, quetiapine fumarate has received regulatory approval as monotherapy for the treatment of adults with depression associated with bipolar disorder. Lithium, anticonvulsant medications (such as valproic acid and lamotrigine), antidepressants, and atypical antipsychotics are also widely used. Available treatment is often not satisfactory in management of the illness, and various combinations must often be employed in an attempt to manage an episode of bipolar depression. New effective and safe treatments are needed for the treatment of depressive states in bipolar disorder.

* Armodafinil as Adjunctive Therapy in Adults with Major Depression associated with Bipolar I

There is some evidence that stimulant medication may have some benefit for depression, with good tolerability. A study evaluating armodafinil treatment for 8 weeks at a dosage of 150 mg/day showed a benefit over placebo treatment as adjunctive therapy for the treatment of patients with major depression associated with bipolar I disorder. On the basis of the results, this program has been developed to evaluate the efficacy of armodafinil treatment at a dosage of 150 mg/day as adjunctive treatment for adults experiencing major depression associated with bipolar I disorder.

* Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

Lurasidone is a novel psychotropic agent for the treatment of bipolar disorder. Lurasidone has been studied in Phase 2 clinical trials, where the compound demonstrated antipsychotic efficacy and a generally favorable safety profile. In addition, a number of large Period 3 studies evaluating the efficacy and safety of lurasidone for the treatment of schizophrenia are ongoing. This research program evaluates the efficacy of lurasidone adjunctive to lithium or divalproex in the treatment of bipolar I depression in individuals who do not respond to treatment with lithium or divalproex alone.