Clinical and Biological Characteristics of Psychotic Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to investigate the relationships among findings in structural and functional neuroimaging, cognitive testing and HPA (hypothalamic-pituitary-adrenal) axis dysregulation in psychotic depression.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genetics of Symptomatology and Treatment Response in Psychotic Major Depression

NCT00691535

Psychotic Disorders Depressive Disorder Depressive Disorder, Major

COMPLETED

Uppsala Psychosis Cohort

NCT05763966

Schizophrenia; Psychosis

RECRUITING

Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis

NCT01688765

Psychotic Disorders

COMPLETED

Acute, Affective, Organic Disorders.

NCT00201474

Depressive Disorders

COMPLETED

Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders

NCT03649581

Schizophrenia

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Eligibility Procedures: Before entering the study and prior to any other procedures, you will be asked to read and sign this consent form. To determine if you are eligible for our study, you will then have a general medical (including menstrual cycle history on female patients) and psychiatric history taken, a physical examination your vital signs (blood pressure, pulse), height, weight, waist/hip ratio will be measured, and various psychiatric evaluations will be conducted. We will be video recording the psychiatric diagnostic assessment of every 5th patient who enrolls in our study.

On Day 1, your mood will be evaluated using a series of commonly used diagnostic instruments and rating scales. We will repeat the medical exam, blood and urine lab tests you had at your initial screening visit if it has been more than 4 weeks (30 days) since your eligibility screening.

The rest of the study includes an MRI, neuropsychological testing, questionnaires, and blood draws.

The MRI (called magnetic resonance imaging, MRI) involves having a picture of your brain taken using a magnet while a series of tasks is administered to you. The MRI scan procedures will take approximately 1 hour.

The neuropsychological testing consists of a series of tests to assess your memory and concentration (neuropsychological means the way your brain processes and completes specific tasks.) This testing, including directions, will take approximately 3 hours of your time. You will also be asked to complete several questionnaires during your hospital stay. These questionnaires ask for your views about your personality, your childhood experiences your quality of life, your mood and a variety of aspects of your daily functioning. The questionnaires may be completed anytime during your stay and will take about 2.5 hours to finish

The blood draws are done at the GCRC, where you will stay for 2 nights.

The following blood draw procedures will be performed for all participants on Day 1: At 4pm on Day 1, an intravenous line (IV; needle inserted into a vein) will be placed in your arm to draw hourly blood samples used for the measure of adrenocorticotropin (ACTH) and cortisol. ACTH is a hormone that controls the release of cortisol (a stress hormone) in your system and both of these hormones levels change under stressful conditions. The blood samples are taken in small amounts (approximately 1/2 teaspoon) and will be collected at 2pm and 4pm on Baseline Day 1, and then on the hour, every hour, starting at 6pm and ending at 9am the next day. A total of 72 ml(approximately 5 tablespoons) of blood will be drawn. The IV line will be removed following the last blood draw. If you presently live in a time zone different from the Pacific Standard Time zone (for example, Eastern Standard Time zone), we may begin taking hourly blood samples as early as 3pm on Baseline Day 1 in order to more accurately measure your body's daily rhythm of hormones.

The following blood draw procedures will be performed for all participants on Day 2: At 2pm on Baseline Day 2, you will have another IV line placed in your arm to draw hourly blood samples used for the measure of ACTH and Cortisol. At 3pm, you will be given 0.5mg (five 0.1mg tablets) of Fludrocortisone. Cortisol and ACTH are taken in small amounts (approximately 1/2 teaspoon) and will be collected on the hour, every hour, starting at 2 pm and ending at 7pm, then every 30 minutes until 12 midnight. Melatonin will be collected at 6:00pm, 7:00pm and then every 30 minutes until 12 midnight. Following the last blood draw, a blood sample will be taken for a clinical laboratory assessment to ensure your safety following Fludrocortisone administration. A total of 66ml's (4 1/2 tablespoons) of blood will be drawn. At 12 midnight, the IV line will then be removed and your vital signs will be taken.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Psychotic Disorders Depressive Disorder, Major

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PMD

Patients diagnosed with major depression with psychotic features

No interventions assigned to this group

NPMD

Patients diagnosed with major depression without psychotic features

No interventions assigned to this group

Controls

Participants with no psychiatric or depression history

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. DSM IV diagnosis of Major Depressive Disorder with or without psychotic features, Bipolar II Disorder with or without psychotic features in a major depressive episode.
2. 21-item HAM-D score greater than or equal to 21.
3. Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items included in the 21-item HDRS.
4. Between 21 - 85 years of age.
5. If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
6. Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.

Exclusion Criteria

1. ECT in the 4 months prior to the study.
2. Abuse of drugs or alcohol in the 6 months prior to study.
3. Unstable or untreated hypertension, or cardiovascular disease.
4. If participating in the blood draw portion of the protocol, endocrine disorders are exclusionary.
5. Use of additional prescription medications, street drugs, or alcohol during the week before the study.
6. Any Axis II diagnosis or traits which would make participation in the study difficult.
7. Current pregnancy or lactation.

1. Personal history of Axis I or Axis II disorders.
2. Active unstable medical problems.
3. Abuse of drugs or alcohol in the 6 months prior to study.
4. Use of additional prescription medications, street drugs, or alcohol during the week before the study.
5. Currently pregnant or lactating.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes