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Completed

NCT Number: NCT02231268

Observational Study to Assess a 6-months Treatment With Gladem

* Evaluation of a 6-months treatment with Gladem * Experiences with the internet for performing a postmarketing study (PMS) trial

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women at least 18 years old
  • De novo prescription of Gladem
  • Treatment with Gladem intended for at least 6 months
  • Depressive disorders

Exclusion criteria

  • Known hypersensitivity against sertraline
  • Concomitant treatment with monoamine oxidase (MAO)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary)
  • Concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine
  • Instable epilepsy

According to product information (October 1998) Gladem prescription was possible with precautions in the following cases:

  • Patients with stable epilepsy
  • Patients with restricted liver functions
  • Suicidal patients
  • Patients in emotional state and marked sleeping disorders

According to product information (October 1998) Gladem should only be prescribed during pregnancy and lactation period, if the expected benefit was greater than the risk. Women of childbearing age should use Gladem only in combination with sufficient contraception.

Treatment and study plan

Gladem

Drug

Primary outcomes

  1. Change in Hamilton Depression Scale (HAMD-6)

    Time frame: 3 months, 6 months

Secondary outcomes

  1. Global assessment of efficacy on a 4-point scale

    Time frame: up to 6 months

  2. Global assessment of compliance on a 4-point scale

    Time frame: up to 6 months

  3. Global assessment of tolerability on a 4-point scale

    Time frame: up to 6 months

  4. Clinical global impression score

    Time frame: up to 6 months

  5. Number of responders

    Time frame: up to 6 months

    >= 50 % reduction in HAMD-6 score

  6. Change in HAMD subscores

    Time frame: baseline, 6 months

  7. Number of patients with adverse drug reactions

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Observational Study Via Internet to Assess a 6-months Treatment With GLADEM

Important dates

Study start
2000
Primary completion
2003
First posted
Sep 4, 2014
Registry last updated
Sep 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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