The BIomarker Guided Study for Depression (BIG)
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|ClinicalTrials.gov Identifier: NCT04181736|
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : December 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Guanfacine Pill Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We will randomize participants to one of two groups, treatment or placebo. Participants will have the option to proceed to an open label phase, post-treatment.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Participants, Care Providers, and Investigators will be blinded throughout the course of the study to avoid bias.|
|Official Title:||Precision Mental Health: Evaluating Biotype-guided Interventions for Depression|
|Actual Study Start Date :||July 1, 2022|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Guanfacine Treatment Group
Participants will be prescribed tabs containing guanfacine immediate release (GIR) to be taken for 4 weeks and will be monitored by one of the study psychiatrists. Subjects randomized to GIR will start with 0.25mg GIR upon waking and increase by 0.25mg every other day with a goal dose of 2mg.
Drug: Guanfacine Pill
Guanfacine immediate release, sold under the brand name Tenex among others, is a medication used to treat high blood pressure and off-label to treat attention deficit hyperactivity disorder (ADHD). It is taken by mouth and will be compounded by a pharmacy to the required doses used in this study.
Placebo Comparator: Placebo Group
Participants will be prescribed tabs containing placebo to be taken for 4 weeks and will be monitored by one of thestudy psychiatrists. Subjects randomized placebo will be asked to follow the same pill regimen as subjects randomized to treatment.
Placebo masked to mirror the treatment drug dose regimen.
- Change in dorsolateral prefrontal cortex (DLPFC) activity [ Time Frame: 4 weeks, 6 weeks ]Activity as evoked by the N-back working memory task
- Change in digit span task performance [ Time Frame: 4 weeks, 6 weeks ]Total number of correct trials in the forward digit span task where each incremental span length has two trials- at least one of which needs to be recalled correctly to progress
- Change in maze task performance [ Time Frame: 4 weeks, 6 weeks ]Time taken to successfully complete the maze without error twice consecutively [for subjects who time out- i.e.- take more than 5 minutes- this score is interpolated from their performance up until that point]
- Change in verbal memory recognition task performance [ Time Frame: 4 weeks, 6 weeks ]Verbal memory total immediate recall trials
- Change in Barratt Impulsiveness Scale (BIS) score [ Time Frame: 4 weeks, 6 weeks ]A questionnaire designed to assess the personality/behavioural construct of impulsiveness--total score and attention items only.
- Change in Hamilton Depression Rating Scale 17-item (HAMD) score [ Time Frame: 4 weeks, 6 weeks ]Clinician rated 17-item overall depression severity score.
- Change in Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 4 weeks, 6 weeks ]Clinician rated global measure of the degree of improvement from initial assessment in overall illness severity.
- Change in Clinical Global Impression of Severity (CGI-S) [ Time Frame: 4 weeks, 6 weeks ]Clinician rated global measure of subject overall illness severity.
- Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) [ Time Frame: 4 weeks, 6 weeks ]A 16-item self-report measure that assesses the severity of depression symptoms in the past week on a 4-point scale ranging from 0 to 3.
- Change in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 4 weeks, 6 weeks ]A scale designed to quantify the severity of suicidal ideation and behavior.
- Change in World Health Organization Quality of Life (WHOQoL) scale [ Time Frame: 4 weeks, 6 weeks ]
A 26-item questionnaire that measures quality of life out of 100 in the following domains:
physical health, psychological health, social relationships, and environment.
- Change in Depression, Anxiety, and Stress Scale (DASS) [ Time Frame: 4 weeks, 6 weeks ]A 42-item self-report scale that assesses symptoms of depression/anhedonia, anxious arousal and generalized anxiety (stress) that are not tied to a particular diagnosis.
- Change in Emotion Regulation Questionnaire (ERQ) [ Time Frame: 4 weeks, 6 weeks ]A 10-item self-report questionnaire designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression.
- Change in Beck Depression Inventory (BDI) [ Time Frame: 4 weeks, 6 weeks ]A 21-item, self-report rating inventory that measures symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex.
- Change in Beck Anxiety Inventory (BAI) [ Time Frame: 4 weeks, 6 weeks ]A 21-item self-report inventory for measuring the severity of common symptoms of anxiety that the participant has had during the past week, such as numbness and tingling, sweating not due to heat, and fear of the worst happening.
- Change in Penn State Worry Questionnaire (PSWQ) [ Time Frame: 4 weeks, 6 weeks ]A 16-item self-report questionnaire that assesses items such as "my worries overwhelm me" and is rated on a likert scale, with scores ranging from 1 to 80.
- Change in Mood and Anxiety Symptom Questionnaire (MASQ) [ Time Frame: 4 weeks, 6 weeks ]A 90-item questionnaire based on the tripartite model of affective disorder which encompasses constructs of anhedonia, anxious arousal and generalized distress, equivalent to the DASS, and which has also been used in healthy and patient groups.
- Change in Sheehan Disability Scale (SDS) [ Time Frame: 4 weeks, 6 weeks ]A 3-item self-report questionnaire that measures functional capacity in work/school, social life, and family life on a scale of 0-10.
- Change in PTSD Checklist - Civilian Version (PLC-C) [ Time Frame: 4 weeks, 6 weeks ]A 17-item self-report scale that measures symptoms of PTSD in the past month on a 5-point scale ranging from 1 to 5.
- Change in Ruminative Responses Scale (RRS) [ Time Frame: 4 weeks, 6 weeks ]A 22-item self-report questionnaire that assesses two aspects of rumination; brooding and reflecting pondering. It is scored on a 4-point scale ranging from 1 to 4.
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 4 weeks, 6 weeks ]A 14-item self-report measure to determine anhedonia levels. It is scored on a 4-point scale of 1 (strongly disagree, disagree) and 0 (strongly agree, agree).
- Change in Fagerstrom Nicotine Dependence Survey (FNDS) [ Time Frame: 4 weeks, 6 weeks ]A short 6-item instrument used for assessing the intensity of physical nicotine addiction.
- Change in Satisfaction With Life Scale (SWLS) [ Time Frame: 4 weeks, 6 weeks ]A short, 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life.
- Change in Health Productivity Questionnaire (HPQ) [ Time Frame: 4 weeks, 6 weeks ]This is a 14-item scale that assesses productivity at work, and relative and absolute levels of absenteeism from work as well as presenteeism (being at work, but unproductive due to the effects of anxiety and depressive symptoms).
- Change in Brief COPE [ Time Frame: 4 weeks, 6 weeks ]A multidimensional coping inventory to assess the different ways in which people respond to stress.
- Change in NIDA-Modified Alcohol, Smoking, and Substance Involvement Screening Test (NM-ASSIST) [ Time Frame: 4 weeks, 6 weeks ]A 15-item measure adapted from the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test, used to assess prescription medicine and illicit substance use in adults age 18 and older.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181736
|Contact: Laura M Hack, MD, PhDemail@example.com|
|Contact: Leanne M Williams, PhDfirstname.lastname@example.org|