Trial Outcomes & Findings for Antidepressant Treatment of Melancholia in Late Life (NCT NCT00000378)

NCT ID: NCT00000378

Last Updated: 2015-10-07

Results Overview

Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 110 participants
• Primary outcome timeframe: BASELINE COMPARED TO 12 WEEK MEASUREMENT
• Results posted on: 2015-10-07

Participant Flow

Participant milestones

Measure	Sertaline patients randomized to sertraline 12 week trial does up to 200mgs Sertraline: 12 week trial dose up to 200mgs	Nortriptyline patients randomized to nortriptyline dose adjusted to therapeutic level Nortriptyline: 12 week trial dose adjusted to therapeutic level
Overall Study STARTED	58	52
Overall Study COMPLETED	42	38
Overall Study NOT COMPLETED	16	14

Reasons for withdrawal

Measure	Sertaline patients randomized to sertraline 12 week trial does up to 200mgs Sertraline: 12 week trial dose up to 200mgs	Nortriptyline patients randomized to nortriptyline dose adjusted to therapeutic level Nortriptyline: 12 week trial dose adjusted to therapeutic level
Overall Study Lack of Efficacy	16	14

Baseline Characteristics

Antidepressant Treatment of Melancholia in Late Life

Baseline characteristics by cohort

Measure	Sertaline n=58 Participants patients randomized to sertraline 12 week trial does up to 200mgs Sertraline: 12 week trial dose up to 200mgs	Nortriptyline n=52 Participants patients randomized to nortriptyline dose adjusted to therapeutic level Nortriptyline: 12 week trial dose adjusted to therapeutic level	Total n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	52 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: BASELINE COMPARED TO 12 WEEK MEASUREMENT

Population: intent to treat analysis

Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement

Outcome measures

Measure	Sertaline n=58 Participants patients randomized to sertraline 12 week trial does up to 200mgs Sertraline: 12 week trial dose up to 200mgs	Nortriptyline n=52 Participants patients randomized to nortriptyline dose adjusted to therapeutic level Nortriptyline: 12 week trial dose adjusted to therapeutic level
HAMILTON Rating Scale for DEPRESSION Range BASELINE	27.3 units on a scale Standard Deviation 6.6	27.1 units on a scale Standard Deviation 4.4
HAMILTON Rating Scale for DEPRESSION Range 12 WEEK DATA	10.7 units on a scale Standard Deviation 8.3	8.4 units on a scale Standard Deviation 7.7

Adverse Events

Sertaline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Nortriptyline

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sertaline n=58 participants at risk patients randomized to sertraline 12 week trial does up to 200mgs Sertraline: 12 week trial dose up to 200mgs	Nortriptyline n=52 participants at risk patients randomized to nortriptyline dose adjusted to therapeutic level Nortriptyline: 12 week trial dose adjusted to therapeutic level
Cardiac disorders orthostatic hypotension	3.4% 2/58	7.7% 4/52

Additional Information

Steven Roose MD

New York State Psychiatric Institute

Phone: 646-774-8661

Email: spr2@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place