Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes

NCT04315597 | Completed Phase 3 DMC

• 2 other identifiers: 209972008-001417-26
• Study Type: interventional
• Target: 398
• Locations: 0 countries
• Sites: N/A

Brief Summary

The researchers in this trial want to learn more about the drug Laif® 900 in preventing the return of signs and symptoms of depressions (also called relapse) in patients suffering from moderate depression episodes. The study drug Laif® 900 is based on Hypericumextract made from the plant St. John wort. Patients will be accepted to take part in the study if they have 20-24 points on the Hamilton Depression Rating Scale (HAM-D) which is a questionnaire helping the doctor to rate the severity of the depression and includes questions on patient's mood, sleep difficulties, agitation, anxiety and weight loss. About 400 patients will be enrolled into the first part of the study and will be treated for 12 weeks with Laif® 900 capsule once daily. Only patients with an improved HAM-D score by 50% will stay in the study and continue with the second part of the study which will last for 24 weeks. In this second part of the study patients will receive either Laif® 900 capsule once daily or an inactive tablet (placebo). Neither the treating doctor nor the patient will know which patient receives the Laif® 900 or placebo. At the end of the study the researcher will assess the effectiveness of the study drug in prevention relapse of depression episodes and will also have more information on the safety of the study drug.

Conditions

Moderate Depressive Episodes (Major Depression)

Outcome Measures

Primary Outcomes (1)

• Relapse rate

  Definition: Increase of the Hamilton rating scale for depression (HAMD)-17 total score in Phase 2 by \> 5 points compared to Phase 2 baseline, if at the same time a total score of at least 12 is reached.

  24 weeks

Secondary Outcomes (5)

• Time between baseline and occurrence of relaps measured by: Total score of HAMD-17

  24 weeks

• Time between baseline and occurrence of relaps measured by: Beck Depression Inventory (BDI)

  24 weeks

• Time between baseline and occurrence of relaps measured by: Clinical Global Impressions (CGI)

  24 weeks

• Global assessment of efficacy by investigators and patients

  12 and 24 weeks

• Safety and Tolerability: Number of Adverse Events

  36 weeks

Study Arms (2)

Hypericum extract STW 3-VI (Laif® 900, BAY98-7108)

EXPERIMENTAL

Drug: Laif® 900, BAY98-7108

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Laif® 900, BAY98-7108 DRUG

1 x daily, 1 tablet, 900 mg

Hypericum extract STW 3-VI (Laif® 900, BAY98-7108)

Placebo DRUG

1 x daily, 1 tablet, 900 mg

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study Phase 1:
• Age 18-70 years
• Diagnosis according to DSM-IV-TR: 296.32: Outpatients with a mediocre depressive episode requiring treatment for recurrent major depression
• At least 5 of the following symptoms must persist for 2 weeks, with at least one of the main symptoms:
• Depressed mood (main symptom)
• Loss of interest or pleasure (main symptom)
• Significant weight loss without diet or weight gain
• Increased sleep or insomnia
• Psychomotor restlessness or slowing down
• Excessive, inappropriate guilt or feelings of worthlessness on almost every day
• Subjective or observable diminished ability to think and to decide
• Fatigue and loss of energy
• Suicidal thoughts and / or actions
• Study Phase 2:
• Phase 1 responders (= Phase 1 patients who have at least a 50% decrease in the HAMD-17 total score after 12 weeks of Laif® 900 therapy).

You may not qualify if:

• Unable to work and patients cared for according to the BtG (working group "Stay") and "Medical Measures")
• Simple mourning reaction
• Clinically relevant laboratory abnormalities due to severe organ and systemic diseases
• Taking immunosuppressants (eg after organ transplants)
• Taking oral contraceptives with low levels of hormones (estrogen ≤ 50 μg, micropillus)
• Thyroid dysfunction (patients with non-euthyroid TSH levels)
• Known intolerance to the test medication
• Known photosensitivity
• Diabetes mellitus type I and II requiring treatment
• Unstable hypertension
• Pregnancy or breastfeeding
• Cancer and AIDS patients (HIV-positive)
• Alcohol, drug or drug abuse in the last 6 months
• Coadministration with coumarin-type anticoagulants
• History of epilepsy

Sponsors & Collaborators

• Bayer: lead
• Steigerwald Arzneimittelwerk GmbH: collaborator

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 19, 2020
• Study Start: March 3, 2009
• Primary Completion: November 22, 2011
• Study Completion: November 22, 2011
• Last Updated: March 19, 2020

Record last verified: 2020-03