Trial · NCT01355523

The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients

NCT01355523, Phase 2, Phase 3, Terminated, Melissa Voigt Hansen; results first posted 2014-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients. Trials, record NCT01355523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01355523

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients
NCT number: NCT01355523
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 54 participants, actual
Lead sponsor: Melissa Voigt Hansen
Conditions: Breast Cancer, Depression
Interventions: Melatonin (N-acetyl-5-methoxytryptamine), Placebo
First posted: 2011-05-18
Last updated: 2014-05-06
Other registries' IDs: eudract:2010-022460-12
Results first posted: 2014-05-06
Limitations and caveats: Premature termination (54/260). Only included about 8% (54/703) of the patients assessed for eligibility.

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Major Depression Inventory (MDI)- Depression at One Point in the Study	Depression at one point in the study (not including baseline) out of 4 measurements at app. day 21, day 35, day 63 and day 91 of the study.	MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument. For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale. Diagnostic scale using the ICD-10 algorithm: Mild depression: 2 core symptoms and 2 other symptoms Moderate depression: 2 core symptoms and 4 other symptoms Severe depression: 3 core symptoms and 5 other symptoms Rating scale: No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50
Primary	Per Protocol - Depression at One Point in the Study Period	Per protocol - depression at one point in the study period (not baseline)	MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument. For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale. Rating scale: No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 This analysis includes only patients who have taken study medication as planned.
Primary	Intention to Treat (Underestimate) - Depression at One Point in the Study Period	Intention to treat (underestimate) - depression at one point in the study period (not baseline)	MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument. For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale. Rating scale: No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as "NO" depression.
Primary	Intention to Treat (Overestimate) - Depression at One Point in the Study Period	Intention to treat (overestimate) - depression at one point in the study period (not baseline)	MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument. For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale. Rating scale: No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as "YES" for depression.
Secondary	Area Under the Curve (AUC) for VAS Data on Anxiety - Immediate Postoperative Period	Daily - from inclusion till 8 days postoperatively	Anxiety measured by VAS (visual analog scale). A subjective feeling of anxiety was registered on a VAS going from "no anxiety", equivalent to 0mm to "worst possible anxiety", equivalent to 100mm. Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively. Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %
Secondary	Area Under the Curve (AUC) for VAS Data on Anxiety - Long-term Postoperative Period	App. 14 days postoperatively till 10 weeks postoperatively	Anxiety measured by VAS (visual analog scale). Completed every 14th day. A subjective feeling of anxiety was registered on a VAS going from "no anxiety", equivalent to 0mm to "worst possible anxiety", equivalent to 100mm. Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day). Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %
Secondary	Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Immediate Postoperative Period	Daily from inclusion till 8 days postoperatively	Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness. Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively. Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %
Secondary	Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Long-term Postoperative Period	App. 14 days postoperatively till 10 weeks postoperatively	Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness. Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day). Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %
Secondary	Area Under the Curve (AUC) for VAS Data on Fatigue - Immediate Postoperative Period	Daily from inclusion till 8 days postoperatively	Fatigue on a Visual Analog Scale - filled out daily. A subjective feeling of fatigue was registered on a VAS going from "no fatigue", equivalent to 0mm to "worst possible fatigue", equivalent to 100mm. Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively. Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %
Secondary	Area Under the Curve (AUC) for VAS Data on Fatigue - Long-term Postoperative Period	App. 14 days postoperatively till 10 weeks postoperatively	Fatigue on a Visual Analog Scale - filled out every 14th day. A subjective feeling of fatigue was registered on a VAS going from "no fatigue", equivalent to 0mm to "worst possible fatigue", equivalent to 100mm. Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day). Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Major Depression Inventory (MDI)- Depression at One Point in the Study	Depression at one point in the study (not including baseline) out of 4 measurements at app. day 21, day 35, day 63 and day 91 of the study.	Includes all patients who have completed at least one other MDI than baseline	participants	NUMBER
PRIMARY	Per Protocol - Depression at One Point in the Study Period	Per protocol - depression at one point in the study period (not baseline)	Includes only patients who have taken the study medication as planned	participants	NUMBER
PRIMARY	Intention to Treat (Underestimate) - Depression at One Point in the Study Period	Intention to treat (underestimate) - depression at one point in the study period (not baseline)	All missing MDI data have been analyzed as NO depression.	participants	NUMBER
PRIMARY	Intention to Treat (Overestimate) - Depression at One Point in the Study Period	Intention to treat (overestimate) - depression at one point in the study period (not baseline)	All missing data have been analyzed as YES depression.	participants	NUMBER
SECONDARY	Area Under the Curve (AUC) for VAS Data on Anxiety - Immediate Postoperative Period	Daily - from inclusion till 8 days postoperatively		mm*day	MEDIAN
SECONDARY	Area Under the Curve (AUC) for VAS Data on Anxiety - Long-term Postoperative Period	App. 14 days postoperatively till 10 weeks postoperatively	Patients were only included in the analysis if they had completed VAS on anxiety in the long-term postoperative period. Single missing data were filled out using last observation carried forward.	mm*2 weeks	MEDIAN
SECONDARY	Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Immediate Postoperative Period	Daily from inclusion till 8 days postoperatively		Units on KSS*day	MEDIAN
SECONDARY	Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Long-term Postoperative Period	App. 14 days postoperatively till 10 weeks postoperatively		Units on KSS*2 weeks	MEDIAN
SECONDARY	Area Under the Curve (AUC) for VAS Data on Fatigue - Immediate Postoperative Period	Daily from inclusion till 8 days postoperatively		mm*day	MEDIAN
SECONDARY	Area Under the Curve (AUC) for VAS Data on Fatigue - Long-term Postoperative Period	App. 14 days postoperatively till 10 weeks postoperatively		mm*2 weeks	MEDIAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Major Depression Inventory (MDI)- Depression at One Point in the Study	Melatonin	NO	24	participants
Major Depression Inventory (MDI)- Depression at One Point in the Study	Placebo	NO	11	participants
Major Depression Inventory (MDI)- Depression at One Point in the Study	Melatonin	YES	3	participants
Major Depression Inventory (MDI)- Depression at One Point in the Study	Placebo	YES	9	participants
Per Protocol - Depression at One Point in the Study Period	Melatonin	NO	24	participants
Per Protocol - Depression at One Point in the Study Period	Placebo	NO	11	participants
Per Protocol - Depression at One Point in the Study Period	Melatonin	YES	3	participants
Per Protocol - Depression at One Point in the Study Period	Placebo	YES	5	participants
Intention to Treat (Underestimate) - Depression at One Point in the Study Period	Melatonin	NO	25	participants
Intention to Treat (Underestimate) - Depression at One Point in the Study Period	Placebo	NO	21	participants

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Melatonin	28
Overall Study	STARTED	Placebo	26
Overall Study	COMPLETED	Melatonin	27
Overall Study	COMPLETED	Placebo	16
Overall Study	NOT COMPLETED	Melatonin	1
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Melatonin	3	27
other	Headache	Nervous system disorders	Placebo	4	24
other	Dizziness	Ear and labyrinth disorders	Melatonin	4	27
other	Dizziness	Ear and labyrinth disorders	Placebo	1	24
other	Sleepiness	Nervous system disorders	Melatonin	1	27
other	Sleepiness	Nervous system disorders	Placebo	1	24
other	Difficulty falling asleep	General disorders	Melatonin	1	27
other	Difficulty falling asleep	General disorders	Placebo	2	24
other	More awakenings at night	General disorders	Melatonin	1	27
other	More awakenings at night	General disorders	Placebo	0	24

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melatonin
Total, all-cause mortality	Placebo
Total, other adverse events	Melatonin	15	27
Total, other adverse events	Placebo	9	24
Total, serious adverse events	Melatonin	0	27
Total, serious adverse events	Placebo	0	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25328711	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Melatonin vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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