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Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

2014-08-27 03:13:46 | BioPortfolio

Summary

The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Depression

Intervention

Armodafinil

Location

Birmingham Psychiatry Pharma
Birmingham
Alabama
United States
35226

Status

Recruiting

Source

Cephalon

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:46-0400

Clinical Trials [1022 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

The primary objective of the study is to determine whether armodafinil treatment, at dosages of 150 and 200 mg/day, is more effective than placebo treatment as adjunctive therapy to mood s...

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

The primary objective of the study is to determine whether armodafinil treatment, at dosages of 150 and 200 mg/day, is more effective than placebo treatment as adjunctive therapy to mood s...

Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative...

PET Study Examining the Dopaminergic Activity of Armodafinil in Adults

The specific aims of this study are 1) to document the DAT receptor occupancy of armodafinil using PET scanning with C-11 altropane as the ligand and 2) to document the increased intrasyna...

Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Cognitive Deficits Associated With Schizophrenia

The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia

PubMed Articles [2546 Associated PubMed Articles listed on BioPortfolio]

Acute hypertensive crisis and severe headache after concurrent use of armodafinil and tranylcypromine: Case report and review of the literature.

Concurrent use of modafinil or armodafinil with monoamine oxidase inhibitors (MAOIs) is contraindicated due to a theoretical risk of drug synergism and acute hypertensive episodes. However, few data a...

Does Armodafinil Improve Driving Task Performance and Weight Loss in Sleep Apnea? A Randomized Trial.

RATIONALE Obstructive sleep apnea (OSA) patients unable to tolerate standard treatments have few alternatives. They may benefit from weight loss, but the major symptom of daytime performance impairmen...

The healthy migrant effect and predictors of perinatal depression.

Although prenatal depression is a risk factor for postpartum depression, current screening tools for prenatal depression fail to predict postpartum depression in some marginalized populations.

Diagnosing and treating bipolar disorder in primary care.

Major depression often presents in patients with a history of both depression and mania, although patients may not have the insight to report manic symptoms as problematic. Distinguishing pure (unipol...

The reciprocal relationship between physical activity and depression: Does age matter?

The level of physical activity (PA) and the prevalence of depression both change across the lifespan. We examined whether the association between PA and depression is moderated by age. As sense of mas...

Medical and Biotech [MESH] Definitions

Decompression external to the body, most often the slow lessening of external pressure on the whole body (especially in caisson workers, deep sea divers, and persons who ascend to great heights) to prevent DECOMPRESSION SICKNESS. It includes also sudden accidental decompression, but not surgical (local) decompression or decompression applied through body openings.

Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. (From DSM-IV, p386)

Depressive states usually of moderate intensity in contrast with major depression present in neurotic and psychotic disorders.

The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.

A propylamine formed from the cyclization of the side chain of amphetamine. This monoamine oxidase inhibitor is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in panic and phobic disorders. (From AMA Drug Evaluations Annual, 1994, p311)

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