Developing New Clinical Management Strategies
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|ClinicalTrials.gov Identifier: NCT02082392|
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : July 7, 2017
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Escitalopram||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Developing New Clinical Management Strategies for Antidepressant Treatments|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 4, 2015|
Placebo Comparator: Clinical Frequency Management
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.
Other Name: Lexapro
Placebo Comparator: Research Frequency Management
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.
Other Name: Lexapro
- Hamilton Rating Scale for Depression [ Time Frame: Baseline week ]
scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 17 items.
sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression
- Hamilton Anxiety Rating Scale (HARS) 14-item Scale [ Time Frame: Baseline week ]Scale for anxiety symptoms administered by trained rater. The HARS is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where <17 indi-cates mild severity, 18-24 mild to moderate severity and25-30 moderate to severe.
- CGI Severity and Improvement [ Time Frame: Baseline week ]
scales developed to measure the clinician's view of subjects' global functioning before and after initiating a study medication. The CGI correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points.
7-point scale: 0 = Not assessed 4 = Moderately ill
1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients
- Treatment Emergent Symptom Scale [ Time Frame: Baseline week ]rating scale for physical symptoms reported during the study. This is a standard means of recording drug-related adverse effects that will allow us to assess whether contact frequency is associated with differences in side effects among study subjects.
- California Pharmacotherapy Alliance Scale (CALPAS)—Clinician Version [ Time Frame: Baseline week ]24 item Likert scale rating the clinician's assessment of the therapeutic alliance, particularly about medication issues, with the patient. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy. Prior studies using the CALPAS reported an association between therapeutic alliance and outcome, and some studies found alliance mediated the effect of expectancy on depression outcome.
- Blind Assessment—Clinician Version [ Time Frame: 8 weeks ]Rates clinician's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.
- Quick Inventory of Depressive Symptoms—Self Report (QIDS-SR) 16 Item Scale [ Time Frame: 8 Weeks ]rating scale for depressive symptoms based on DSM criteria. A self-report measure for depressive symptoms is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies (e.g., STAR*D) due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression
- Treatment Credibility and Expectancy Scale (CES) [ Time Frame: 8 Weeks ]8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. For this study, the primary measure of expectancy will be item 4: "By the end of the treatment period, how much improvement in your depressive symptoms do you think will occur?" (0-100%).
- Client Satisfaction Questionnaire 8 (CSQ 8) [ Time Frame: 8 Weeks ]self-administered scale with items rating respondents' satisfaction with mental health services they are receiving on a 4 point Likert scale. Use of the CSQ 8 will allow us to determine whether CFM and RFM are associated with differences in participant satisfaction.
- Cornell Treatment Preference Index [ Time Frame: 8 weeks ]scale used in mental health studies to document the type and strength of patients' treatment preferences. We will use a modified version in this study asking subjects "Based on your experience and how you feel right now, which of the visit frequencies in this study would be your first choice?" The strength of this preference will be measured on a 5-point Likert scale.
- Revised Life Orientation Test (LOT-R) [ Time Frame: 8 weeks ]scale developed to assess individual differences in generalized optimism versus pessimism. Degree of optimism on this scale has been correlated with the magnitude of placebo response observed in studies of placebo analgesia, and we will determine whether LOT-R scores moderate effects of therapeutic contact.
- Schedule for Adaptive and Nonadaptive Personality (SNAP) [ Time Frame: 8 weeks ]this questionnaire is a widely used assessment tool for personality disorders that we will also use to identify predictors of response to varying visit frequency.
- California Pharmacotherapy Alliance Scale (CALPAS)—Patient Version [ Time Frame: 8 weeks ]24 item Likert scale rating the patient's assessment of the therapeutic alliance, particularly about medication issues, with the clinician. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy.
- Blind Assessment—Patient Version [ Time Frame: 8 weeks ]rates subject's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.
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): NCT02082392
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Bret Rutherford, MD||New York State Psychiatric Institute|