Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01370733
Eligibility Criteria:
Inclusion Criteria:
* Subjects will meet the DSM-IV-TR primary diagnosis of initial or recurrent Major Depressive Disorder by DSM-IV-TR criteria rendered by structured interview using the Mini International Neuropsychiatric Interview (MINI).
* HAM-D17 score \>= 17 and Item 1 score greater than or equal to 2.
* Duration of current episode \>=8 weeks. The definition of an episode is demarcated by a period of \>=2 months when the subject did not meet full criteria for the DSM-IV-TR definition of Major Depressive Episode. Maximum duration of current episode cannot exceed 2 years.
* The baseline EEG is of sufficient duration and quality that it can be processed for quantitative analysis.
* Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.
Exclusion Criteria:
* Subjects are unable or unwilling to give informed consent.
* Diagnosed with the following conditions (current unless otherwise stated):
* Any other current primary Axis I mood, anxiety, or psychotic disorder, including bipolar disorder.
* Depression secondary to a general medical condition, or substance-induced.
* History of substance abuse or dependence within the past 6 months (except nicotine and caffeine).
* Any bipolar disorder or psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes.
* Eating disorder (current or within the past year).
* Obsessive compulsive disorder (lifetime).
* Post-traumatic stress disorder (current or within the past year).
* ADHD (currently being treated).
* Subjects meeting criteria for Axis II cluster A or B diagnosis based upon DSM-IV TR criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.
* Subjects with a clinically defined neurological disorder including, but not limited to:
* Any condition likely to be associated with increased intracranial pressure.
* Space occupying brain lesion.
* Any history of seizure EXCEPT those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study).
* History of stroke.
* Transient ischemic attack within two years.
* Cerebral aneurysm.
* Dementia.
* Mini Mental Status Exam (MMSE-2) score of =\<24.
* Parkinson's disease.
* Huntington's disease.
* Multiple sclerosis.
* Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Medications that lower the seizure threshold are included in the Prohibited Concomitant Medication (Section 5.7).
* Subjects who are currently hospitalized due to severity of depression symptoms.
* Subjects with any of the following treatment histories:
* TMS treatment within 6 months prior to the screening visit.
* ECT treatment within 1 year prior to the screening visit.
* Failure to respond to TMS or ECT treatment (i.e., consistent with ATHF confidence level 3 or higher) in this or any previous episode.
* Lifetime history of treatment with Deep Brain Stimulation or Vagus Nerve Stimulation.
* Use of any investigational drug or device within 4 weeks of the randomization visit.
* Subjects who have been treated with fluoxetine within the past four weeks.
* If participating in psychotherapy, must have been in stable treatment for at least 2 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the trial.
* Failure to respond to Monoamine Oxidase Inhibitors (MAOIs) in the current episode.
* Use of any medication(s) listed on the Prohibited Concomitant Medication within 1 week of randomization.
* Subjects are adequately benefiting from current antidepressant medication(s).
* Significant acute suicide risk, defined as:
* Suicide attempt within the previous 6 months that required medical treatment; or
* Greater than or equal to 1 suicide attempts in the past 12 months; or
* Has a clear-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study; or
* In the Investigator's opinion, is likely to attempt suicide within the next 6 months.
* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
* Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed.
* Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
* Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.
* Positive urine drug screen for illicit substances. (A positive urine drug screen at screening may be repeated once prior to randomization).
* Any condition which in the judgment of the Investigator would prevent the subject from completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT01370733
Study Brief:
Protocol Section:
NCT01370733