Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Depression

NCT00157547 | Completed Phase 4 DMC

• 1 other identifier: 2002-P-001784
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to try to see if antidepressant medications cause changes in QEEG measurements in the brain. QEEG is a mathematical analysis of electrical currents in the brain using electrodes placed on the scalp. Previous studies have shown that mood improvement (clinical response) caused by antidepressant medications was preceded by changes in QEEG measurements in the brain.

Conditions

Major Depressive Disorder

Keywords

Depression; Quantitative EEG (QEEG); Antidepressants

Outcome Measures

Primary Outcomes (1)

• Ham-D-17

  8 weeks

Interventions

Selective serotonin reuptake inhibitors (SSRI) DRUG

Selective serotonin reuptake inhibitors (SSRI)

Also known as: fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram, venlafaxine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV diagnostic criteria for MDD
• Written informed consent
• Men or women aged 18-65
• A baseline Hamilton-D17 score of \> 16 at screen visit

You may not qualify if:

• Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
• Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
• Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematological disease
• History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
• History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
• History of multiple adverse drug reactions
• Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants. Concomitant use of antihistamine drugs will be allowed.
• Patients who have failed to respond during the course of their current major depressive episode to at least two adequate antidepressant trials, or have failed more than one adequate trial with an SSRI antidepressant.
• Electroconvulsive therapy (ECT) within the past 6 months

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Medtronic - MITG: collaborator

Related Publications (1)

• Iosifescu DV, Greenwald S, Devlin P, Mischoulon D, Denninger JW, Alpert JE, Fava M. Frontal EEG predictors of treatment outcome in major depressive disorder. Eur Neuropsychopharmacol. 2009 Nov;19(11):772-7. doi: 10.1016/j.euroneuro.2009.06.001. Epub 2009 Jul 1.

  PMID: 19574030 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Selective Serotonin Reuptake Inhibitors; Fluoxetine; Sertraline; Paroxetine; Fluvoxamine; Citalopram; Escitalopram; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Propylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oximes; Hydroxylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids

Study Officials

• Dan Iosifescu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2003
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 28, 2008

Record last verified: 2008-05